FELASA Module 1: Legislation
EU learning outcomes
Trainees should be able to:
1.1. Identify and describe the national and EU laws and guidance which regulate the
scientific use of animals and in particular the activities of those carrying out scientific
procedures involving them.
1.2. Identify and describe related animal welfare legislation.
1.3 Describe the authorisation that is needed before acting as user, breeder or
supplier of laboratory animals and especially the authorisation required for projects
and where applicable individuals.
1.4. List sources of information and support that are available (regarding national
legislation).
1.5. Describe the role of the personnel mentioned in Article 24, 25 and 26, and their
statutory duties and other responsibilities under the National Legislation.
1.6. Describe the roles and responsibilities of the local animal welfare bodies and the
national committee for the protection of animals used for scientific purposes.
1.7. Indicate who is responsible for compliance at an establishment and how this
responsibility may be exercised (e.g. through the local AWB).
1.8. Describe when a procedure becomes regulated under National legislation
(minimum threshold of pain, suffering, distress or lasting harm).
1.9. Indicate who bears primary responsibility for the animals undergoing procedures.
1.10. List which species, including respective stages of development that are included
in the scope of the Directive / National law.
1.11. Indicate the circumstances in which animals under the scope of the Directive
should be humanely killed or removed from the study to receive veterinary treatment.
1.12. Describe the legislative controls over the killing of animals bred or used for
scientific procedures
2.5. Describe how the law is based on an ethical framework which requires 1)
weighing the harms and benefits of projects (the harm/benefit assessment) 2)
applying the Three Rs to minimise the harm, maximise benefits and 3) promote good
animal welfare practices.
2.8. Describe the concept of harms to animals including avoidable and unavoidable
suffering,direct, contingent and cumulative suffering.
2.9. Describe the severity classification system, and give examples of each category.
Describe cumulative severity and the effect this may have on the severity
classification.
2.10. Describe the regulations regarding re-use of animals.
9.3. Recognise that there are ethical limits to what it is considered permissible to do
under the Directive and that even within these legal constraints, there are also likely
to be national and
institutional differences in this respect.
, 9.4. Explain that legislation requires that the justification for programmes of work is
assessed by weighing potential adverse effects on the animals against the likely
benefits; that harms to
animals must be minimised, and benefits maximised.
11.1. Describe in detail the main components of the national legislation regulating the
scientific use of animals; in particular, explain the legal responsibilities of those
designing procedures and projects (Function B staff) and those of other persons with
statutory responsibilities under the national legislation (e.g. the person responsible for
compliance, veterinarian, animal care staff, training officers).
11.2. List the key purposes of other relevant EU and international legislation and
associated guidelines that impact on the welfare and use of animals. This includes
Directive 2010/63/EU and legislation/guidelines relating to: veterinary care, animal
health, animal welfare, genetic modification of animals, animal transport, quarantine,
Health & Safety, wildlife and conservation.
11.19. Explain the need to be aware of local arrangements relating to project licence
management, e.g. procedures for ordering animals, accommodation standards,
disposal of animals, safe working practices and security, and the actions to take in the
event of unexpected problems arising with any of these.
European Laboratory Legislation
Need global harmonisation in how we treat animals when looking at scientific
advancement
Council of Europe is a voluntary collaboration established after WWII
They primarily protect human rights but have also been handling animal welfare
issues for the last 50 years
Most council members are European countries
The council issues conventions that the member states can sign if they agree
on the content
It is voluntary whether member states implement conventions into their
national legislation
The member states meet in Strasbourg in France to set up conventions and
discuss their interpretations
Conventions can also be discussed by non-governmental organizations
such as animal welfare societies and industry
However these groups do not have a vote
The EU issues directives which all member states have to adhere to
The EU began in 1957 and developed as an economic collaboration mostly
relevant for industrial competition until the Mastricht Treaty
From 1993 the Masticht Treaty regulates a range of issues for all parts of
European society
Council of Europe = voluntary conventions
EU = mandatory directives for members
1986- Council of Europe issued European Convention for the Protection of
Vertebrate Animals used for Experimental and Other Scientific Purposes
6 months later EU issued their first directive about protection of animals used
for experimental and other scientific purposes
Very much a copy of the council of Europe convention
Minimum directive which means that member states could have stricter rules
in their own national legislation but not weaker
EU learning outcomes
Trainees should be able to:
1.1. Identify and describe the national and EU laws and guidance which regulate the
scientific use of animals and in particular the activities of those carrying out scientific
procedures involving them.
1.2. Identify and describe related animal welfare legislation.
1.3 Describe the authorisation that is needed before acting as user, breeder or
supplier of laboratory animals and especially the authorisation required for projects
and where applicable individuals.
1.4. List sources of information and support that are available (regarding national
legislation).
1.5. Describe the role of the personnel mentioned in Article 24, 25 and 26, and their
statutory duties and other responsibilities under the National Legislation.
1.6. Describe the roles and responsibilities of the local animal welfare bodies and the
national committee for the protection of animals used for scientific purposes.
1.7. Indicate who is responsible for compliance at an establishment and how this
responsibility may be exercised (e.g. through the local AWB).
1.8. Describe when a procedure becomes regulated under National legislation
(minimum threshold of pain, suffering, distress or lasting harm).
1.9. Indicate who bears primary responsibility for the animals undergoing procedures.
1.10. List which species, including respective stages of development that are included
in the scope of the Directive / National law.
1.11. Indicate the circumstances in which animals under the scope of the Directive
should be humanely killed or removed from the study to receive veterinary treatment.
1.12. Describe the legislative controls over the killing of animals bred or used for
scientific procedures
2.5. Describe how the law is based on an ethical framework which requires 1)
weighing the harms and benefits of projects (the harm/benefit assessment) 2)
applying the Three Rs to minimise the harm, maximise benefits and 3) promote good
animal welfare practices.
2.8. Describe the concept of harms to animals including avoidable and unavoidable
suffering,direct, contingent and cumulative suffering.
2.9. Describe the severity classification system, and give examples of each category.
Describe cumulative severity and the effect this may have on the severity
classification.
2.10. Describe the regulations regarding re-use of animals.
9.3. Recognise that there are ethical limits to what it is considered permissible to do
under the Directive and that even within these legal constraints, there are also likely
to be national and
institutional differences in this respect.
, 9.4. Explain that legislation requires that the justification for programmes of work is
assessed by weighing potential adverse effects on the animals against the likely
benefits; that harms to
animals must be minimised, and benefits maximised.
11.1. Describe in detail the main components of the national legislation regulating the
scientific use of animals; in particular, explain the legal responsibilities of those
designing procedures and projects (Function B staff) and those of other persons with
statutory responsibilities under the national legislation (e.g. the person responsible for
compliance, veterinarian, animal care staff, training officers).
11.2. List the key purposes of other relevant EU and international legislation and
associated guidelines that impact on the welfare and use of animals. This includes
Directive 2010/63/EU and legislation/guidelines relating to: veterinary care, animal
health, animal welfare, genetic modification of animals, animal transport, quarantine,
Health & Safety, wildlife and conservation.
11.19. Explain the need to be aware of local arrangements relating to project licence
management, e.g. procedures for ordering animals, accommodation standards,
disposal of animals, safe working practices and security, and the actions to take in the
event of unexpected problems arising with any of these.
European Laboratory Legislation
Need global harmonisation in how we treat animals when looking at scientific
advancement
Council of Europe is a voluntary collaboration established after WWII
They primarily protect human rights but have also been handling animal welfare
issues for the last 50 years
Most council members are European countries
The council issues conventions that the member states can sign if they agree
on the content
It is voluntary whether member states implement conventions into their
national legislation
The member states meet in Strasbourg in France to set up conventions and
discuss their interpretations
Conventions can also be discussed by non-governmental organizations
such as animal welfare societies and industry
However these groups do not have a vote
The EU issues directives which all member states have to adhere to
The EU began in 1957 and developed as an economic collaboration mostly
relevant for industrial competition until the Mastricht Treaty
From 1993 the Masticht Treaty regulates a range of issues for all parts of
European society
Council of Europe = voluntary conventions
EU = mandatory directives for members
1986- Council of Europe issued European Convention for the Protection of
Vertebrate Animals used for Experimental and Other Scientific Purposes
6 months later EU issued their first directive about protection of animals used
for experimental and other scientific purposes
Very much a copy of the council of Europe convention
Minimum directive which means that member states could have stricter rules
in their own national legislation but not weaker
