Animal Experimentation Ordinance

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In The Matter OfAnimal Experimentation Ordinance
Exhibit A
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English is not an official language of the Swiss Confederation. This translation is provided for information purposes only and has no legal force.

Art. 12 Basic principles of recording strain in small rodents

(Art. 124 AniWO) 1 The recording of strain in small rodents must be documented. The following data must be entered: a. results of inspections in accordance with Annex 4; b. time and date of inspections and person carrying out inspections. 2 The frequency of inspections and the traits to be observed shall be constantly adjusted based on new findings from monitoring or from animal experiments. 3 Measures for reducing strain and criteria for euthanasia must be implemented immediately. The implementation must be documented.

Art. 13 Recording strain in small rodents

(Art. 124 AniWO) 1 The head of the laboratory animal facility is responsible for recording strain. In particular, he or she shall ensure that: a. the persons involved in monitoring genetically modified lines or lines that have a clinical pathological phenotype: 1. have sufficient time to carry out and document the inspection in a manner that best ensures the welfare of the animals, 2. maintain state-of-the-art knowledge in the field of recording strain, 3. are immediately informed about new findings on clinical signs of strain in the lines to be assessed; b. the basic principles stated in Article 12 are adhered to. 2 The list of traits to be checked in accordance with Annex 4 shall be supplemented for each line with traits that can be expected or not excluded on the basis of the genetic modification. 3 Strain records and reproduction and mortality data shall be constantly evaluated and compared with existing data on animals with the same genetic background.

Art. 14 Recording strain in new or insufficiently characterised lines of small rodents

(Art. 124 AniWO) 1 New or insufficiently characterised lines of genetically modified small rodents shall be inspected for traits in accordance with Annex 4 while changing cages and observed at least once in between cage changes. 2 Newborn animals shall be inspected for traits in accordance with Annex 4 within the first five days and thereafter checked and observed at intervals as defined in paragraph 1 until they are weaned. 3 During the first three generations, all animals shall be checked and observed as stipulated in paragraphs 1 and 2. 4 If a total of 100 animals from at least three generations have been checked and no signs of strain have been detected, the line is deemed to be free of clinical pathological phenotype.

Art. 15 Recording strain in small rodent lines likely to have a clinical pathological phenotype

(Art. 124 AniWO) 1 A small rodent line is deemed likely to have a clinical pathological phenotype if: a. evidence of genetically related strain is found in several animals; or b. analysis of the data shows increased mortality or reproduction problems. 2 In lines likely to have a clinical pathological phenotype, Article 14 applies to recording strain.

Art. 16 Recording strain in small rodent lines that have a clinical pathological phenotype

(Art. 124 AniWO) In lines that have a clinical pathological phenotype, the scope of the inspections and the list of traits to be studied and documented shall be stipulated in the decision in accordance with Article 127 AniWO.

Art. 17 Provisional reporting of strain in small rodent lines

(Art. 126 and 145 para. 1 let. a AniWO) 1 If similar signs of strain are found in several animals of a new or insufficiently characterised line or of a line likely to have a clinical pathological phenotype, the head of the laboratory animal facility must report the strain observed to the cantonal authorities (provisional report). 2 The provisional report must contain the following information: a. a precise description of the signs of strain observed in the summary of the strain record; b. basic scientific data as specified in Annex 2; c. planned additional observations; d. planned or initiated measures to reduce strain and its expected impact; e. planned euthanasia criteria. 3 The provisional report must be submitted within two weeks of the strain being observed. 4 If strain is confirmed by additional recordings, the head of the laboratory animal facility must submit a definitive report in accordance with Article 18. If the initial strain is not confirmed, he or she must likewise repor

Para. 2 let. e — Inserted by No I of the FSVO O of 20 Dec. 2024, in force since 1 Feb. 2025 (AS 2025 25).

Art. 18 Definitive report of strain in small rodent lines

(Art. 126 and 145 para. 1 let. a AniWO) 1 The definitive report of strain in small rodent lines must be submitted at the latest when 100 animals have been checked in accordance with Article 14. 2 The definitive report must contain the following information: a. basic scientific data as specified in Annex 2; b. specific observation plan and results of strain recording, including degree of severity; c. measures to be taken to reduce strain and its impact; cbis. the euthanasia criteria to be applied; d. weighing the observed strain on the animals against the potential benefit for research, therapy or diagnostics and the likelihood of this benefit being realised; e. intended scope of breeding and the number of animals to be used in animal experiments.

Para. 2 let. cbis — Inserted by No I of the FSVO O of 20 Dec. 2024, in force since 1 Feb. 2025 (AS 2025 25).

Art. 19 Recording strain in new or insufficiently characterised fish lines

(Art. 124 AniWO) 1 In the case of new or insufficiently characterised lines of genetically modified fish, the recording of strain includes: a. observation of swimming behaviour and, if possible, swarm behaviour; b. recording of reproduction performance; c. check on general health; d. test for clinical symptoms; e. test for morphological changes. 2 The reproduction data shall be constantly evaluated and compared with existing data on animals with the same genetic background.

Art. 20 Recording strain in fish lines that probably have a clinical pathological phenotype

(Art. 124 AniWO) 1 A fish line is regarded as probably having a clinical pathological phenotype if: a. evidence of genetically related strain is found in several animals; or b. analysis of the data shows increased mortality or reproduction problems. 2 In fish lines that probably have a clinical pathological phenotype, Article 19 applies to recording strain.

Art. 21 Recording strain in fish lines that have a clinical pathological phenotype

(Art. 124 AniWO) In fish lines that have a clinical pathological phenotype, the scope of the inspections and the list of traits to be studied and documented shall be stipulated in the decision in accordance with Article 127 AniWO.

Art. 22 Reporting procedure for genetically modified fish lines that have a clinical pathological phenotype

(Art. 126 and 145 para. 1 let. a AniWO) The report of a genetically modified fish line that has a clinical pathological phenotype comprises the information defined in Article 126 paragraph 2 AniWO including the weighing of strain against benefits as specified in Article 18 paragraph 2 letter d of this Ordinance.

Art. 23 Data sheet for genetically modified lines and mutants that have a clinical pathological phenotype

(Art. 124 AniWO) 1 In the case of genetically modified lines and mutants that have a clinical pathological phenotype, the most important information shall be entered in a summarising document (data sheet). The data sheet contains the following information: a. the basic scientific data in accordance with Annex 2; b. a summary of strain recording in accordance with Annex 3; c. where applicable, the decision on lines that have a clinical pathological phenotype (Art. 127 AniWO). 2 The data sheet shall be submitted to the cantonal authorities at the latest when an application for animal experiments using the line or mutant in question is submitted for approval or when a report is submitted concerning this line or these mutants. 3 It serves as a communication in accordance with Article 13 of the Containment Ordinance of 25 August 1999 when genetically modified animals are moved from one enclosed system to another. When a new line that is not yet sufficiently characterised or a line that prob

Para. 3 — [AS 1999 2783, 2003 4793 No I 3, 2006 4705 No II 82, 2007 4477 No IV 35, 2008 4377 Annex 5 No 6. AS 2012 2777 Art. 33 No 1]. See now: the O of 9 May 2012 (SR 814.912).