Rs 455.163 Order Of The Fsvo Of April 12, 2010, Concerning The Detention Of Experimental Animals, The Production Of Genetically Modified Animals And The Methods Used In Animal Experimentation (Ordinance On Animal Experimentation)

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)

Subscribe to a Global-Regulation Premium Membership Today!

Key Benefits:

Subscribe Now for only USD$20 per month, or Get a Day Pass for only USD$4.99.
455.163 order of the FSVO concerning detention of animals of experience, the production of genetically modified animals and the methods used in animal experimentation (Ordinance on animal experimentation) of April 12, 2010 (State on May 1, 2010) the federal Office of food safety and Veterinary Affairs (FSVO), view the art. 124, al. 2, 136, al. 2, 142, al. 4 and 209, al. 1 of the Ordinance of 23 April 2008 on the protection of animals (OPAn), stop: Section 1 purpose art. 1 this order regulates: a. the detention of experimental animals; b. the production, breeding and livestock experience GM and mutants with a phenotype invalidating; c. the characterisation and documentation of the constraint, and the reporting procedure; (d) the determination of the degree of severity of the constraints; e. experiments on animals made in several cantons; f. requests and statements relating to pet stores and animal testing.

Section 2 custody of the animals to experience art. 2 monitoring of experimental animals (art. 121 OPAn) technical facilities, ventilation and Automatic watering systems, are to be secured by means of an alarm if their failure, as a result of a breakdown or malfunction, would be likely to cause injury to the animals.
The State of the environment are held where animals, including bedding, food and water, as well as the welfare of the animals will be checked daily.
The well-being of small rodents is controlled during their transfer in own cages. These animals will also be a 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 during the weekends if concrete data on the surveillance last attest that the animals suffer no lack of control.
Small rodents, means the animals referred to in annex 3, table 1, OPAn.
In the case of a constraint in an animal, it will be posted on the cage or enclosure by affixing of distinctive brands.
The frequency of inspections referred to in paras. 2 and 3 will be increased according to the stress suffered by the animals.
The results of the controls carried out are to be recorded in the minutes.

Art. 3 individual keeping of animals socially incompatible (art. 119, para. 2, OPAn) the dates of the beginning and the end of individual possession of socially incompatible animals so that the particular facts observed during this detention are to be recorded in the minutes.

Art. 4 output of dogs (art. 71, para. 2, OPAn) out of dogs can take place in an outdoor enclosure.

Art. 5 marking of small rodents (art. 120 OPAn) marking of small rodents for the breeding can be done through invasive methods, such the tattoo, the installation of an electronic chip, the amputation of the distal phalange of a finger or ear piercing.
The marking of small rodents not intended for breeding through invasive methods is possible only if it is justified by the relevant experience and he will always have to be motivated.
The marking by means of ear tags is prohibited.
The necessary marking for genotyping is to combine with the biopsy.

Art. 6 interventions and measures in the premises where animals are held (art. 135, para. 9, OPAn) interventions and the following measures may be carried out in premises where animals are held: a. marking; b. administration of substances by injection of short duration or by gavage; c. samples of blood, hair, urine or saliva, for example.

Art. 7 documentation (art. 114 OPAn) the assignment of persons in the care of experimental animals and their mode of operation will be listed in an understandable way.
In the premises of the pet store, it will be clear for each animal that is responsible for the compliance with the provisions on the protection of animals.
Documentation related to the characterization of the constraint and the criteria for judgment of experience must be accessible to the staff at any time.

Art. 8 level of training of the personnel assigned to the care of animals (art. 116 OPAn) a third at least of equivalent jobs full time assigned to the animal care must be occupied by individuals having trained as the keeper of animals referred to in art. 195 OPAn.

Section 3 Production, breeding and keeping of animals of GM experience and mutants with a phenotype invalidating art. 9 recognized methods for the production of genetically modified animals (art. 142, para. 4, OPAn) recognized methods for the production of genetically modified animals are listed in annex 1.
A method can be recognized if it is widely used and, compared with other processes, it is respectful of the animals. The criteria to be taken into account are both interventions and enforcement measures as the success rate and the number of surplus animals.
The recognized methods will be applied in a way that respects animals and according to a standard protocol.
Pet stores are at the disposal of the cantonal authority of approval a statement of success rate in the application of the recognized methods. If this rate is insufficient, the pet store takes adequate corrective measures.

Art. 10 genotyping (art. 120, para. 1 and 123, OPAn) methods or combination of methods are allowed for genotyping in the production and breeding of genetically modified animals: a. non-invasive methods such as the examination of feces or saliva; (b) of the methods that can be combined with the marking of animals; c. to blood.

The tail biopsies are admitted only if they are justified by experience concerned and motivated. It is forbidden to collect more than 5 mm of tail.
The following methods combining marking and genotyping are allowed in small rodents: a. the amputation of the distal phalange of a finger in the twelve days following the birth. It is permissible to amputate to maximally two distal phalanges by animal; b. the marking by drilling or notch in the ear after weaning.

Art. 11 Phenotyping (art. 124 OPAn) the sacrifice of animals for anatomical or pathological and examinations such as behavior to light stress tests and blood samples are allowed in the production and breeding lines or animal strains if they are running to describe the characteristics of the lines and the stem. These reviews will be done in a respectful way of animals.

Section 4 characterisation and documentation of the constraint, and reporting procedure art. 12 principles for the characterization of the constraint in small rodents (art. 124 OPAn) characterization of the constraint in small rodents will be documented. Will be so recorded: a. the results of the inspections referred to in Schedule 4; (b) the date and time controls as well as the name of the person who performed it.

The frequency of inspections and special to look for signs will be reviewed as and when on the basis of the results of monitoring or experience.
Measures reducing the constraint and the judgment of experience criteria will be applied without delay. This application will be documented.

Art. 13 implementation of the characterization of the constraint in small rodents (art. 124 OPAn) the pet store manager is responsible for the characterization of the constraint in small rodents. It shall particularly ensure that: a. the those overseeing genetically modified lines or with a disabling phenotype: 1 sufficient time to conduct a review of the lines that is both successful and respectful of the animals, and to document, 2 are always abreast of the latest state of knowledge in the field of the characterization of the constraint 3. are informed without delay of any new element relating to the constraint of the lines to assess;

b. principles defined in art. 12 are respected.

The list of features to control within the meaning of annex 4 must be completed for each line by the specific signs which, due to the genetic modification concerned, are likely or less possible.
The information from the characterization of the constraint as well as data on reproduction and mortality will be evaluated as their acquisition and compared with the available information and data related to animals with the same genetic background.

Art. 14 characterisation of the constraint in the lines not enough hardcore of small rodents (art. 124 OPAn) not enough hardcore of small rodents genetically modified or new lines or new will be controlled during the change of cage to identify any particular signs in the sense of annex 4, and they will be a simple Visual check at least once between each change of cage.
Newborns will be controlled within five days of birth to identify any particular signs in the sense of annex 4. They will be then checked at the pace set at the al. 1 until weaning.

All animals referred to in paras. 1 and 2 will be controlled during the first three generations.
A line is deemed not to present a phenotype disabling if total 100 animals obtained during at least three generations have been checked and that no constraint was identified during these checks.

Art. 15 characterization of stress in lines of small rodents likely to present a phenotype invalidating (art. 124 OPAn) a line of small rodents is deemed likely to present a constraint: a. If signs of genetic origin constrained were noted in several animals. forgotten the source. If the analysis of the data revealed a higher mortality or reproductive problems.

In the case of lines likely to be a constraint, the characterization of the constraint is performed in accordance with art. 14 art. 16 characterization of the constraint with lines of small rodents with a phenotype invalidating (art. 124 OPAn) in lines with a disabling phenotype, the scale controls and the list of specific signs to examine and document will be identified in the decision referred to in art. 127 OPAn.

Art. 17 provisional notification of constraints at lines of small rodents (art. 126, and 145, para. 1, let. a, OPAn) If several small rodents from new or not enough hardcore lines or genetically modified lines may have a disabling phenotype present similar constraints, the pet store manager notifies the constraints observed in the cantonal authority of authorization (provisional notification).
The interim notification must contain the following information:. in the summary of the characterisation of the constraint, an accurate description of constraints observed; b. the scientific data base referred to in Schedule 2; c. extra points that it is planned to consider; (d) the measures planned or taken to reduce the constraint and their effects likely.

The interim notification is to be transmitted within a period of two weeks from the recognition of the constraints.
If the constraints identified in the characterization of the constraint are confirmed, the person responsible for the pet store will perform a final notification within the meaning of art. 18 if the identified constraints initially do not confirm to, it will notify it also to the cantonal authority.

Art. 18 final notification of the constraints observed in lines of small rodents (art. 126, and 145, para. 1, let. a, OPAn) final notification of constraints observed in lines of small rodents is to perform at the latest after 100 animals have been inspected in accordance with art. 14. the final notification must contain the following data: a. basic scientific information referred to in Schedule 2; b. a plan of observation of the animals and the results of the characterization of the constraint, including the category of constraint; c. steps to take to reduce the stress, and their effects, d. the weighing of interests between constraints on animals and the potential usefulness of the lineage for research , the diagnosis or the treatment in humans or animals, including the likelihood that this utility becomes effective; e. the size of the colony to farming and the number of animals it is planned to use in experiments.

Art. 19 characterization of the constraint in the lines of fish new or not sufficiently characterized (art. 124 OPAn) characterization of the constraint in new or not enough hardcore of genetically modified fish lines includes: a. the observation of the behavior swim and, if possible, the behavior of the bench; b. registration of reproductive performance; c. the control of the general welfare; d. research of clinical symptoms; e. research of morphological alterations.

The reproduction data will be analysed as their acquisition and compared with available data in animals with the same genetic background.

Art. 20 characterization of the constraint in the lines of fish likely to present a phenotype invalidating (art. 124 OPAn) a line of fish is likely to present a disabling phenotype: a. If genetic origin constrained indices were noted in several animals. forgotten the source. If the analysis of the data indicates a higher mortality or reproductive problems.

The characterization of the constraint in the lines of fish likely to a disabling phenotype is performed in accordance with art. 19 art. 21 characterisation of the constraint in the lines of fish with a phenotype invalidating (art. 124 OPAn) in the lines of fish with a disabling phenotype, the scale controls and the list of specific signs to control and document will be identified in the decision referred to in art. 127, OPAn.

Art. 22 procedure for notification of the lineages of fish genetically modified with a disabling phenotype (art. 126, and 145, para. 1, let. a, OPAn) notification of a lineage of fish genetically modified with a phenotype invalidating must include the information referred to in art. 126, al. 2, OPAn, including the weighing of the interests referred to in art. 18, al. 2, let. d of the present order.

Art. 23 record of data on genetically modified lines and mutants with a phenotype invalidating (art. 124 OPAn) information relating to the genetically modified lines and mutants with a disabling phenotype are to be registered in a summary document (data sheet). This data sheet must include the following information: a. basic scientific information referred to in Schedule 2; (b) a summary of the characterisation of the constraint in the sense of annex 3; (c) if applicable, the decision on the lines with a phenotype invalidating (art. 127 OPAn).

Data sheet will be given to the cantonal authorities at the latest when the filing of the application for authorization to perform experiments on animals with the line or the mutants in question, or when the notification of the lineage or the mutants to the cantonal authority.
Data sheet serves communication within the meaning of art. 13 of the order of 25 August 1999 on the use of bodies confined in case of transfer of genetically modified animals to a confined in another. At the time of the assignment of a new line that has not yet been sufficiently serious or a line likely to present a disabling phenotype, he will also be awarded to the purchaser all data collected on this date.

[RO 1999 2783, 2003 4793 c. I 3, 2006 4705 ch. II 82, 2007 4477 ch. IV 35, 2008 4377 annex 5 ch. 6] HAVE 2012 2777 art. 33 CH 1]. See now the O of 9 may 2012 (SR 814.912).

Section 5 Determination of the degree of severity of the Art. constraint 24 categorization of the stress caused by interventions or measures as part of the experience (art. 136, al. 2, OPAn) constraints caused by interventions or measurements made in an experiment on animals are classified in one of four categories: a. degree of severity 0 - absence of constraint: interventions and manipulations on animals for experimental purposes, causing the animals nor pain , no harm or damage, causing no anxiety and that disrupt not their general well-being; b. severity 1 - slight constraint: interventions and manipulations in animals for experimental purposes which cause animals pain or damage either light and short-lived, either slightly disruptive general well-being; c. degree of severity 2 - mean stress : interventions and manipulations in animals for experimental purposes which cause animals pain, headaches or damage either medium and short duration, or light and medium to long duration, average short-term anxiety, either a significant disturbance and short or medium of their general well-being; d. severity 3 - severe constraint : interventions and manipulations in animals for experimental purposes which cause great pain to animals, or the pains of average intensity and average to long, or the evils of medium to large and long lasting, damage, or damage of medium and medium to long term, be a great anxiety of long-term , is a significant disruption of their general well-being.

Art. 25 categorization of constraints caused by a genetic modification (art. 136, para. 2, OPAn) constraints caused by genetic changes are classified into four categories:

a. degree of severity 0 - absence of constraint: genetic changes that cause animals pain, hurt or damage, that don't cause them anxiety and that do not disrupt their overall well-being; b. degree of severity 1 - slight constraint: genetic changes that cause animals pain or minor damage or slightly disruptive general well-being; c. degree of severity 2 - mean stress : genetic changes that cause animals to pain, headaches or damage of medium degree, anxiety or a disruption of their general well-being; d. degree of seriousness 3 - severe constraint: genetic changes that cause animals of great pains, headaches of long duration, significant damage, a lot of anxiety or a significant disruption of their general well-being.

Art. 26 constraints to be taken into account for the assessment of the proportionality of an experience (art. 136, para. 2, OPAn) for the assessment of the proportionality of an experience, account will be taken of the constraints referred to in art. 24 and 25 and other constraints suffered by animals because of their debasement, of deep interventions in their phenotype or skills, or to excessive exploitation.

Section 6 experiments on animals made in several cantons art. 27 (art. 139, para. 2, OPAn) notifications of experiments performed in several cantons must mention the number of animals used in each of the cantons.
If the animals are moved from one canton to another going experience, their number will be entered only in the canton where the experience took place mainly.

Section 7 applications and statements relating to pet stores and experiments on animals art. 28 content of the application for authorization to operate a pet shop (art. 122 OPAn) the application for authorization to operate a pet store must contain the following information: a. the destination of the animal facility; (b) the animal species kept and the capabilities of the pet store by species of animal; c. the number and size of premises, such as detention facilities of the animals, the laboratory, the procedure rooms and ancillary premises as well as the environmental conditions in space and lighting; (d) the facilities of detention, hygiene standards, the regulation of access to the premises and the cleaning standards; e. standards of supervision applicable to food, cages and detention facilities f. the origin of animals, genetic modification, the marking and the detention of animals; g. methods of production, farming and the detention of genetically modified animals or lines with a disabling phenotype; h. monitoring of health system; i. how to dispose of dead animals; j. the emergency plan; k. the name of the Manager of the pet store with his acting; l. the number of employees and their qualifications; Mr. description of the control of the number of animals and, where applicable, documentation related to the characterization of the constraint.

Art. 29 contents of declarations made by pet stores (art. 145, al. 1, let. b, OPAn) declarations made by pet stores must contain the following information: a. the number of animals born in the premises, counted at weaning; (b) the number of animals imported from abroad.

The number of animals should be mentioned per animal species.
The lines with a disabling phenotype must be reported individually. Their name and on their respective data sheet must match.
If the lines are not disabling phenotype, they must be reported for each animal species, by grouping: a. genetically modified lines; b. non genetically modified lines.

Art. 30 content of the application for authorization to perform experiments on animals (art. 139, para. 1, OPAn) the application for authorization to perform experiments on animals must contain the following information: a. the animal species, number, sex and the origin of the animals to be used; (b) the use of genetically modified animals and mutants with a phenotype disabling, including the form data to the senses of the art. 23 of this order and, where appropriate, the decision referred to in art. 127 OPAn; c. address of the pet store; d. the premises, infrastructure and the place where will be made experience; e. the name of the Director of animal experimentation, the Director of experience, their alternates and the experimenters; f. the number of employees and their qualifications; g. the purpose of experience; h. the method that will be used, including the timing of the different parts of the experience the date of the interim analysis of the results and, where applicable, the date interim reports; i. the total duration of the experience; j. the predictable effects of constraints on the general well-being of the animals, including the degree of severity of the constraints for each part of the experience or for each group k. system of monitoring of animals and the criteria for judgment of experience; l. analysis of the results of experience; Mr. justification for experience the method of the stress suffered by the animals and the number of animals used; n. weighing of interests.

Art. 31 contents of statements on the animal experiments (art. 145, al. 2, OPAn) statements on the animal experiments must contain the following information: a. the species of animal used, if any affiliation to a genetically modified line or line with a phenotype invalidating; b. the number of animals used per calendar year; c. origin of animals; d. the stress suffered by the animals; e. the use of animals one times over experience; e. results and the evaluation of the experience.

Declarations must be made in all cases, that the experience has taken place or not.

Section 8 entry into force art. 32. this order comes into force on May 1, 2010.

Annex 1 (art. 9, para. 1) recognized methods for the production of genetically modified animals a. genetically modified lines crossing; b. the injection therefor in the mouse, rat, rabbit and pig India; c. the injection and the aggregation of embryonic mice and rat; (d) the use of the mouse and the rat viral vectors; e. ICSI sperm in mice; f. the injection of embryos on a stage of early development (stage 1 to 16 cells) in the cytoplasm or in the yolk sac of zebrafish.

State on January 1, 2014, annex 2 (art. 17, al. 2, let. b, 18, al. 2, let. a and 23, al. 1 let. a) basic scientific information breeding lines following information must be provided: a. animal species; b. the name of the line; (c) the type of genetic modification, the reference of the data bank , the bibliographic information, the purpose of production line; d. the producer, the method of production, the year of production, the generation, breeding status (suspended, Cryopreserved); e. genotype, genetic background, health status.

State on January 1, 2014, annex 3 (art. 23, al. 1, let. b) summary of the characterisation of the constraint the following information relating to execution of the characterization of the constraint and its result must be provided: a. extent of the characterization of the constraint, the results from data on mortality and reproduction; b. State of the characterization of the constraint (being determined work notified, completed); (c) the description of the phenotype, the assessment of the constraint, the degree of compulsion, the expression of a transgene (dominant or recessive, conditional, inducible); d. the specific needs, measures of constraint.

State on January 1, 2014, annex 4 (art. 12, al. 1, let. a, 13, para. 2 and 14, al. 1 and 2) characterization of the constraint in genetically modified lines of small rodents and the mutants with a phenotype disabling table 1: characterization of the constraint among small rodents genetically modified lines and mutants with a phenotype disabling controls of the nest (art. 14 al. 2 and 15, al. (2) controls during the change of cage (art. 14, para. 1 and 15, para. 2) number of youth, color, differences in size x x intake foods (milk spot) general health state x (size, tone, nutritional status, etc.)

x x visible with the naked eye Malformations x x number of dead animals, cannibalism, post-mortem if necessary x x other significant characters, as for example examination. wounds due to a bite x x clinical symptoms (cramps, tremors, lameness, etc.)

x x according to the type of genetic modification: other morphological characteristics x x behavior during the change of cage (apathy, fear, etc.)

x Construction of the nest, the nest x coat, eyes, body cavity searches x State State on January 1, 2014

Related Laws