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RS 455.163 Order of the OSAV of 12 April 2010 concerning the possession of animals of experience, the production of genetically modified animals and the methods used in animal testing (Animal Testing Ordinance)

Original Language Title: RS 455.163 Ordonnance de l’OSAV du 12 avril 2010 concernant la détention des animaux d’expérience, la production d’animaux génétiquement modifiés et les méthodes utilisées dans l’expérimentation animale (Ordonnance sur l’expérimentation animale)

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455.163

FVO Ordinance on the Detention of Experimental Animals, the Production of Genetically Modified Animals and the Methods Used in Animal Experimentation

(Animal Testing Ordinance)

On 12 April 2010 (State 1 Er May 2010)

The Federal Office for Food Safety and Veterinary Affairs (OSAV) 1 ,

Having regard to art. 124, para. 2, 136, para. 2, 142, para. 4 and 209, para. 1 of the Order of 23 April 2008 on the protection of animals (OPAn) 2 ,

Stops:

Section 1 Purpose

Art. 1

This Order governs:

A.
The possession of experimental animals;
B.
The production, breeding and holding of genetically modified animals and mutants with a disabling phenotype;
C.
The characterization and documentation of the constraint, and the reporting procedure;
D.
Determining the degree of severity of the stresses;
E.
Animal experiments carried out in several cantons;
F.
Requests and declarations relating to pet animals and animal experiments.

Section 2 Retention of experienced animals

Art. 2 Monitoring of experienced animals

(art. 121 OPAn)

1 Technical installations, such as ventilation and automatic watering systems, are to be secured by means of an alarm if their failure, due to a breakdown or malfunction, would result in damage to the animals.

2 The state of the environment in which animals are held, including litter, food and water, as well as animal welfare, will be monitored daily.

3 The well-being of small rodents is controlled when they are transferred to clean cages. These animals will also be subject to visual examination three times a week at least. It is not necessary to monitor the state of the environment and the well-being of small rodents on weekends if concrete data on past surveillance attest to the fact that animals do not suffer from the lack of control.

4 Small rodents refer to the animals listed in Appendix 3, Table 1, OPAn.

5 In the case of a finding of a constraint in an animal, it will be reported on the cage or enclosure by the affixing of distinctive marks.

6 The frequency of controls referred to in paras. 2 and 3 will be increased depending on the strain on the animals.

7 The results of the checks carried out are to be recorded in minutes.

Art. 3 Individual custody of socially incompatible animals

(art. 119, para. 2, OPAn)

The dates of the start and end of the individual detention of socially incompatible animals, as well as the particular facts observed during that detention, are to be recorded in minutes.

Art. 4 Release of Dogs

(art. 71, para. 2, OPAn)

The exit of the dogs can take place in an open-air enclosure.

Art. 5 Marking of small rodents

(art. 120 OPAn)

1 Marking of small rodents for breeding can be done using invasive methods such as tattooing, electronic chip placement, ear piercing or the amputation of the distal phalanx of a finger.

2 The marking of small non-breeding rodents using invasive methods is only possible if justified by the relevant experience and will always have to be motivated.

3 Marking by means of ear tags is prohibited.

4 The necessary labelling for genotyping is to be combined with the biopsy.

Art. 6 Interventions and measures in the premises where the animals are held

(art. 135, para. 9, OPAn)

The following actions and measures may be taken at the premises where the animals are held:

A.
Marking;
B.
Administration of substances by short injection or by gavage;
C.
Sampling of blood, hair, urine or saliva, for example.
Art. 7 E. Documentation

(art. 114 OPAn)

1 The assignment of persons to the care of experienced animals and their working instructions will be listed in an understandable manner.

2 In the pet store, it will be clearly stated for each animal that is responsible for compliance with the animal protection provisions.

3 Documentation of the stress characterization and the criteria for stopping the experiment should be available to staff at any time.

Art. 8 Level of training of personnel assigned to the care of animals

(art. 116 OPAn)

At least one-third of equivalent full-time equivalent jobs in animal care must be filled by persons who have been trained as an art keeper. 195 OPAn.

Section 3 Production, husbandry and possession of genetically modified animals and mutants with a disabling phenotype

Art. Recognized Methods of Genetically Modified Animal Production

(art. 142, para. 4, OPAn)

1 Recognized methods of producing genetically modified animals are listed in Appendix 1.

2 A method can be recognized if it is widely used and if, in comparison to other processes, it is respectful of animals. The criteria to be taken into account are both the implementation of the interventions and the measures that the success rate and the number of animals supernumerary.

3 Recognized methods will be applied in an animal-friendly manner and in accordance with a standard protocol.

4 The animalies shall make available to the Cantonal Authority a record of the success rate in the application of the accepted methods. If this rate is insufficient, the pet shop will take appropriate corrective action.

Art. 10 Genotyping

(art. 120, para. 1 and 123, OPAn)

1 The following methods or combination of methods are allowed for genotyping in the production and rearing of genetically modified animals:

A.
Non-invasive methods such as faecal or saliva testing;
B.
Methods that can be combined with animal marking;
C.
Blood samples.

2 Tail biopsies are allowed only if they are justified by the relevant and motivated experience. It is forbidden to take more than 5 mm from the tail.

3 The following methods combining tagging and genotyping are allowed in small rodents:

A.
The amputation of the distal phalanx of a finger within 12 days of the birth; a maximum of two distal phalanges per animal may be amputated;
B.
Ear piercing or ear tapping after weaning.
Art. 11 Phenotyping

(art. 124 OPAn)

The sacrifice of animals for anatomical or pathological purposes and examinations such as light stress tests and blood samples are permitted in the production and breeding of lines or strains Animals if they are performed to describe the characteristics of the lines and strains. These examinations will be carried out in an animal-friendly manner.

Section 4 Characterization and documentation of the constraint, and reporting procedure

Art. 12 Principles for Characterization of Constraint in Small Rodents

(art. 124 OPAn)

1 Characterization of stress in small rodents will be documented. This will include:

A.
The results of the controls referred to in Annex 4;
B.
The date and time of the controls and the name of the person who performed them.

2 The frequency of the controls and the specific signs to be searched will be re-examined on the basis of the results of the monitoring or experience.

3 The measures reducing the constraint and the criteria for stopping the experiment will be applied without delay. This application will be documented.

Art. 13 Implementation of stress characterization in small rodents

(art. 124 OPAn)

1 The leader of the animalerie is responsible for the strain characterization in small rodents. In particular, it ensures that:

A.
Persons who are responsible for monitoring genetically modified or incapacitating phenotypes:
1.
Have sufficient time to conduct a review of the lines that are both conclusive and respectful of the animals, and to document it,
2.
Are always aware of the latest state of knowledge in the field of stress characterization,
3.
Be informed without delay of any new element relating to the constraint of the lines to be evaluated;
B.
The principles defined in s. 12 are respected.

2 The list of specific signs to be controlled within the meaning of Annex 4 must be completed for each line by the specific signs which, because of the genetic modification concerned, are likely or at least possible.

3 Information from the stress characterization, as well as data on reproduction and mortality, will be evaluated as they are acquired and compared with available information and data on Animals with the same genetic background.

Art. 14 Characterization of stress in new or insufficiently characterized lines of small rodents

(art. 124 OPAn)

1 New or insufficiently characterized lines of small, genetically modified rodents will be controlled during the change of cage to detect any specific signs within the meaning of Annex 4, and will be the subject of a simple Visual inspection at least once between each change of cage.

2 Newborns will be screened within five days of birth to identify any specific signs within the meaning of Schedule 4. They will then be controlled at the rate set out in para. 1 to weaning.

3 All animals referred to in paras. 1 and 2 will be monitored for the first three generations.

4 A line is deemed not to have a debilitating phenotype if a total of 100 animals obtained in at least three generations have been controlled and no constraints have been detected in these controls.

Art. 15 Characterization of stress in lines of small rodents that may have a debilitating phenotype

(art. 124 OPAn)

1 A line of small rodents is considered likely to present a constraint:

A.
Whether there are indications of genetic stress in several animals; or
B.
If data analysis revealed higher mortality or reproductive problems.

2 In the case of strains capable of presenting a stress, the characterization of the constraint is carried out in accordance with art. 14.

Art. 16 Characterization of stress in lines of small rodents with a debilitating phenotype

(art. 124 OPAn)

In the incapacitating phenotype, the extent of the controls and the list of specific signs to be examined and documented will be specified in the decision under s. 127 OPAn.

Art. 17 Provisional notification of constraints in small rodent lines

(art. 126 and 145, para. 1, let. A, OPAn)

1 If several small rodents from new or insufficiently characterized lines or genetically modified lines likely to have a debilitating phenotype have similar constraints, the leader of the animalerie shall notify the Constraints observed in the Cantonal Authorization Authority (interim notification).

2 The provisional notification must contain the following information:

A.
In the summary of the stress characterization, a precise description of the observed constraints;
B.
The basic scientific data referred to in Annex 2;
C.
The additional items to be considered;
D.
Measures planned or taken to reduce the stress and their likely effects.

3 The provisional notification shall be transmitted within two weeks of the finding of the constraints.

4 If the constraints identified in the stress characterization are confirmed, the leader of the animal will make a definitive notification within the meaning of s. 18. If the constraints initially identified are not confirmed, it will also notify the cantonal authority.

Art. 18 Final notification of constraints observed in small rodent lines

(art. 126 and 145, para. 1, let. A, OPAn)

1 The definitive notification of stresses in small rodent lines is to be carried out at the latest after 100 animals have been checked in accordance with art. 14.

2 The final notification shall contain the following data:

A.
The basic scientific information referred to in Annex 2;
B.
An animal observation plan and the results of the stress characterization, including the constraint category;
C.
The measures to be taken to reduce the constraint and their effects;
D.
The weighing of the interests between the constraints on animals and the potential usefulness of the line for research, diagnosis or treatment in humans or animals, including the likelihood of this utility becoming effective;
E.
The size of the colony for breeding and the number of animals expected to be used in experiments.
Art. 19 Characterization of stress in new or insufficiently characterized fish lines

(art. 124 OPAn)

1 Characterization of stress in novel or uncharacterized inbred lines of genetically modified fish includes:

A.
Observation of swimming behaviour and, if possible, the behaviour of the bench;
B.
Recording of reproductive performance;
C.
General welfare control;
D.
Seeking clinical symptoms;
E.
The search for morphological alterations.

2 Breeding data will be analyzed as they are acquired and compared with available data for animals with the same genetic background.

Art. Characterization of stress in fish lines likely to have a debilitating phenotype

(art. 124 OPAn)

1 A fish line is likely to have a disabling phenotype:

A.
Whether genetic stress indices have been found in several animals; or
B.
If data analysis indicates higher mortality or reproductive problems.

2 The stress characterization in fish lines that are capable of presenting a debilitating phenotype is carried out in accordance with art. 19.

Art. Constraint characterization in fish lines with a debilitating phenotype

(art. 124 OPAn)

In fish lines with a debilitating phenotype, the scope of controls and the list of specific signs to be monitored and documented will be specified in the decision under s. 127, OPAn.

Art. Procedure for the notification of genetically modified fish lines with a disabling phenotype

(art. 126 and 145, para. 1, let. A, OPAn)

The notification of a line of genetically modified fish with a disabling phenotype shall contain the information referred to in Art. 126, para. 2, OPAn, including the weighing of interest referred to in s. 18, para. 2, let. D of this order.

Art. Data sheet on genetically modified lines and mutants with a debilitating phenotype

(art. 124 OPAn)

1 The main information on the genetically modified lines and the mutants with a disabling phenotype are to be entered on a summary document (data sheet). This data sheet should contain the following information:

A.
The basic scientific information referred to in Annex 2;
B.
A summary of the stress characterization as defined in Annex 3;
C.
Where appropriate, the decision on incapacitating phenotypes (art. 127 OPAn).

2 The data sheet shall be given to the cantonal authority at the latest at the time of the application for authorisation to practice animal experiments with the line or mutants in question, or when notification of the line or mutants to the The cantonal authority.

3 The data sheet is a communication within the meaning of s. 13 of the Order of August 25, 1999, on the use of confined organisms 1 In the case of the transfer of genetically modified animals from one enclosed environment into another. At the time of the transfer of a new lineage that has not yet been sufficiently characterized or of a lineage capable of presenting a disabling phenotype, it will also be given to the recipient all the data collected on that date.


1 [ RO 1999 2783 , 2003 4793 Ch. I 3, 2006 4705 ch. II 82, 2007 4477 ch. IV 35, 2008 4377 Annex 5, c. 6. AS 2012 2777 art. 33 hp. 1]. See currently O of 9 May 2012 (RS 814.912 ).

Section 5 Determination of the severity of the stress

Art. 24 Categorization of the constraint caused by interventions or measures in the experiment

(art. 136, para. 2, OPAn)

Constraints caused by interventions or measures taken in the context of an animal experiment are classified in one of the following four categories:

A.
Severity 0 - No constraint: Interventions and manipulations on animals for experimental purposes that do not cause animals or pain, harm or damage, cause no anxiety and do not disturb their general well-being;
B.
Degree of severity 1-mild stress: Interventions and manipulations on animals for an experimental purpose that cause pain or damage to animals either mild and short-lived, or which cause slight disturbance to their general welfare;
C.
Degree of severity 2-mean stress: Interventions and manipulations on animals for an experimental purpose that causes pain, injury or damage to animals either medium and short duration, either mild and long-lasting, or average anxiety Short duration, a significant disturbance and short or average duration of general well-being;
D.
Degree of severity 3-severe stress: Interventions and manipulations on animals for experimental purposes that cause animals to be of great pain, medium and long-term pain, or moderate to long-term pain Duration, either significant damage, medium and long-term damage, long-term anxiety, or a significant disruption to their overall well-being.
Art. 25 Categorizing constraints caused by genetic modification

(art. 136, para. 2, OPAn)

The constraints caused by genetic modification are classified into four categories:

A.
Severity 0 - No constraint: Genetic modifications that do not cause animals or pain, harm or damage, cause them no anxiety and do not disturb their general well-being;
B.
Degree of severity 1-mild stress: Genetic modifications that cause animals to cause minor or minor damage to their general well-being;
C.
Degree of severity 2-mean stress: Genetic modifications that cause animals to suffer from pain, pain or damage of a moderate degree, anxiety or disruption of their general well-being;
D.
Degree of severity 3-severe stress: Genetic modifications that cause animals to experience severe pain, long-term pain, significant damage, anxiety or significant disruption to their general well-being.
Art. 26 Constraints to be taken into account in assessing the proportionality of an experiment

(art. 136, para. 2, OPAn)

In assessing the proportionality of an experiment, account shall be taken of the constraints referred to in Art. 24 and 25 and other stresses suffered by animals due to their oiling, profound interventions in their phenotype or in their abilities, or excessive instrumentalization.

Section 6 Animal experiments carried out in several cantons

Art. 27

(art. 139, para. 2, OPAn)

1 Notifications concerning experiments carried out in several cantons must mention the number of animals used in each of the cantons.

2 If the animals are moved from one canton to another in the course of experience, their number will be entered only in the canton where the experience has taken place mainly.

Section 7 Requests and declarations concerning pet animals and animal experiments

Art. 28 Contents of the application for authorization to operate a pet store

(art. 122 OPAn)

The application for authorization to operate a pet store must contain the following information:

A.
The destination of the animal;
B.
Animal species held and the capacity of animal handlers by animal species;
C.
The number and size of the premises, such as the premises of the animals, the laboratory, the intervention rooms and the premises, as well as the ambient conditions in the premises and the lighting;
D.
Detention facilities, hygiene standards, access regulations and cleaning standards;
E.
Monitoring standards for food, cages and detention facilities;
F.
The origin of animals, genetic modification, marking and holding of animals;
G.
Methods of production, rearing and holding of genetically modified animals or lines with a disabling phenotype;
H.
The health surveillance system;
I.
The method of disposing of animal carcasses;
J.
The contingency plan;
K.
The name of the person responsible for the pet store and his or her alternate;
L.
Number of employees and their qualifications;
M.
The description of the control of the animal population and, where appropriate, the documentation relating to the characterization of the constraint.
Art. Content of statements to be made by the animalies

(art. 145, para. 1, let. B, OPAn)

1 The statements to be made by the animals must contain the following information:

A.
The number of animals born in the facility, counted at the time of withdrawal;
B.
The number of animals imported from abroad.

2 The number of animals must be mentioned by animal species.

3 Lines with a disabling phenotype must be reported individually. Their names and the names on their respective data sheets must correspond.

4 If the lines do not have a debilitating phenotype, they must be reported for each animal species by grouping:

A.
Genetically modified lines;
B.
Non-genetically modified lines.
Art. Content of the application for authorisation to practice experiments on animals

(art. 139, para. 1, OPAn)

The application for authorisation to conduct animal experiments shall contain the following information:

A.
The animal species, number, sex and origin of the animals to be used;
B.
The use of genetically modified animals and mutants with a disabling phenotype, including the data sheet within the meaning of s. 23 of this order and, where applicable, the decision under s. 127 OPAn;
C.
The address of the animal;
D.
Premises, infrastructure and the place where the experiment will be conducted;
E.
The name of the Director of Animal Experimentation, the Director of Experience, their alternates and the experimenters;
F.
Number of employees and their qualifications;
G.
The purpose of the experiment;
H.
The method to be used, including the timing of the different parts of the experiment, the date of the interim analysis of the results and, where appropriate, the date of the intermediate reports;
I.
The total duration of the experiment;
J.
The foreseeable effects of constraints on the general welfare of animals, including the degree of severity of the constraints for each part of the experiment or for each group;
K.
The animal monitoring system and the criteria for stopping the experiment;
L.
Analysis of the results of the experiment;
M.
Justification of the experience, method, strain of animals and number of animals used;
N.
The weighing of interests.
Art. Content of declarations on animal experiments

(art. 145, para. 2, OPAn)

1 The declarations on animal experiments should contain the following information:

A.
The animal species used, if any, belonging to a genetically modified or lineage containing a disabling phenotype;
B.
The number of animals used per calendar year;
C.
The origin of animals;
D.
Stress on animals;
E.
Use of animals after experience has been completed;
F.
The results and assessment of the experience.

2 Statements must be made in all cases, whether or not the experience occurred.

Section 8 Entry into force

Art. 32

This order shall enter into force on 1 Er May 2010.

Annex 1

(art. 9, para. 1)

Methods recognized for the production of genetically modified animals

A.
The crossing of genetically modified lines;
B.
Pronuclear injection in mice, rats, rabbits, and pigs;
C.
The injection and aggregation of embryonic stem cells in mice and rats;
D.
The use of viral vectors in mice and rats;
E.
Intracytoplasmic sperm injection in mice;
F.
Injection of embryos at an early stage of development (stage 1 to 16 cells) in the cytoplasm or in the zebra fish yolk sac.

State 1 Er January 2014

Annex 2

(art. 17, para. 2, let. B, 18, para. 2, let. A and 23, para. 1, let. (a)

Basic scientific information

The following information on breeding lines should be provided:

A.
The animal species;
B.
The name of the line;
C.
The type of genetic modification, the reference of the database, the bibliographic information, the purpose of the production of the line;
D.
The producer, the method of production, the year of production, the generation, the state of the breeding (suspended, cryopreserved);
E.
Genotype, genetic background, health status.

State 1 Er January 2014

Annex 3

(art. 23, para. 1, let. (b)

Constraint Characterization Summary

The following information regarding the execution of the stress characterization and its result should be provided:

A.
The extent of stress characterization, results from mortality and reproductive data;
B.
The state of the stress characterization work (being determined, notified, completed);
C.
Description of the phenotype, assessment of stress, degree of stress, expression of a transgene (dominant or recessive, conditional, inducible);
D.
The specific needs, the reduction measures of the constraint.

State 1 Er January 2014

Annex 4

(art. 12, para. 1, let. A, 13, para. 2 and 14, para. 1 and 2)

Characterization of stress in genetically modified small rodent lines and mutants with a debilitating phenotype

Table 1: Characterization of stress in genetically modified small rodent lines and in mutants with a debilitating phenotype

Nest Controls (art. 14, para. 2 and 15, para. 2)

Controls when changing the cage (art. 14, para. 1 and 15, para. 2)

Number of youth, colour, size differences

X

X

Food (milk spot)

X

General health status (size, tone, nutritional status, etc.)

X

X

Malformations visible to the naked eye

X

X

Number of dead animals, cannibalism, post-mortem examination if applicable

X

X

Other striking signs, such as wound sores

X

X

Clinical symptoms (tremors, cramps, limbo, etc.)

X

X

Depending on the type of genetic modification: other specific morphological features

X

X

Behaviour during cage change (apathy, spawning, etc.)

X

Nest construction, nest condition

X

Pelage, eyes, body orifices

X


State 1 Er January 2014