A. Purpose and applicability B. Legal principles and formal aspects of the reports... 2

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1 Bundesamt für Veterinärwesen Office vétérinaire fédéral Ufficio federale di veterinario Uffizi federal veterinar Information Animal protection 1.03 Reports on animal experiments: Explanatory notes for Form C Contents Page A. Purpose and applicability... 2 B. Legal principles and formal aspects of the reports... 2 C Explanations of the individual sections... 3 Heading: Number of the licence... 3 Heading: Final report/interim report... 3 Heading: Year of the report... 3 Heading: Intercantonal experiment... 3 Heading: Short title of the project... 3 Section 1: Address of resource manager... 4 Section 2: Address of cantonal authority... 4 Section 3: Completion of the experiment / continuation in the following year... 4 Section 4: Number of animals used in the calendar year... 4 Section 5: Origin of the animals used... 6 Section 6: Retrospective degree of severity... 7 Section 7: Elimination or further use of the animals... 9 Section 8: Assessment of the experiment Section 9: The undersigned resource manager Final section: Confirmation by the cantonal authority V1.3 august 2011

2 - 2 - A. Purpose and applicability The legislator wishes to establish clarity in respect of animal experimentation and, by doing so, to promote an objective discussion of this controversial topic. The Swiss Federal Veterinary Office publishes annual statistics covering all experiments on animals. These contain the information needed to assess the application of the legislation on the animal welfare (art. 36, Animal Welfare Act, TSchG; RS 455). In the compilation and publication of statistics, compliance with international rules and recommendations is required (see art. 147, para. 2, Animal Welfare Ordinance, TSchV; RS 455.1). For this the collection of complete and reliable data on the number of animals used in the experiments, their origin and the purpose of their use, the adverse effects of the experiment is needed etc. For this purpose, all persons who conduct animal experiments must present an annual report (Form C; cf. art. 145, paras 2 and 4 TSchV). The information contained in Form C is also consulted during the verification of animal experiments already conducted. The purpose of these explanatory notes for Form C is to facilitate the drafting of reports and so to reduce the number of subsequent enquiries made by the authorities. They are to be regarded as a work of reference for consultation if any doubts arise over the completion of individual sections of Form C. The explanatory notes for Form C are intended for all holders of a cantonal permit to conduct animal experiments and for the authorizing authorities. These explanations only relate to Form C. Separate explanations apply to Form A (Applications; FVO no (e)). B. Legal principles and formal aspects of the reports The responsible resource manager shall report completion of experiments within two months of their completion to the cantonal authority by means of Form C. Where experiments continue over a number of years, the notification must be given with the requisite information for the past calendar year by the end of February at the latest (see art. 145, para. 1, TSchV ). The reports are to be submitted according to the form template of the Federal Veterinary Office (Form C), cf. art. 31, para. 1 Animal Experiment Ordinance, TVV). The form are available for download here: The original and one copy of the report are to be submitted to the cantonal authority, which may require further copies from the licence holder. Further instructions given by the cantonal authorities, e.g. as to whether copies of cited literature are to be attached, must be respected. Note: Once the information system e-tierversuche is operational, reports are to be completed online (art. 145 para 2 TSchV). If no animal experiments are carried out within the context of an existing licence during the reporting year,

3 - 3 - it is sufficient to send the cantonal authorities a brief notification ( , letter) to this effect instead of the completed form. C Explanations of the individual sections The explanations of the individual sections show the purpose for which a particular item of information is required, the content that is expected and particular details to be noted. The explanatory examples given for some sections clarify the required content. Heading: Number of the licence PURPOSE OF ENTRY: Clear identification of the report and association with the corresponding licence. Enter the official licence number (see Form B or possibly pre-numbered by the cantonal authority). EXAMPLES: 2361 BE118/09 ZG21 Heading: Final report/interim report PURPOSE OF ENTRY: Fast and unambiguous identification of completed research projects (final report: close file). For research projects which are to be continued under the same licence number in the following year, the reports are regarded as interim reports. Mark a cross in the appropriate box. Heading: Year of the report PURPOSE OF ENTRY: Clear identification of the reporting year. Enter the year. Heading: Intercantonal experiment PURPOSE OF ENTRY: Rapid identification of cross-cantonal animal experiments. Tick where applicable Heading: Short title of the project PURPOSE OF ENTRY: To facilitate identification of the report by the authorities and cantonal committees. This information is used for verification purposes if the licence number does not coincide.

4 - 4 - Use the same wording as on the licence (Form B). The short title should indicate the purpose of the experiment and give references to the animal model or method used. EXAMPLES: Experimental meningitis in mice. Polyclonal antibodies of chickens against enzymes which influence DNA replication. Section 1: Address of resource manager PURPOSE OF ENTRY: Used for correspondence with the authorities. Postal address of the institute, laboratory or company, together with name, telephone number and of the resource manager. Section 2: Address of cantonal authority PURPOSE OF ENTRY: Used for correspondence with the authorities. Postal address of the responsible cantonal authority (generally pre-printed, e.g. Kantonales Veterinäramt Zürich, Domaine de l'expérimentation animale, Direction générale de la santé, Genève) Section 3: Completion of the experiment / continuation in the following year PURPOSE OF ENTRY: To inform the authorities whether the animal experiment has already been completed at the time of reporting or is to be continued (subject to the validity of the licence). Mark a cross in the appropriate box. Where necessary indicate the month and year of completion of the experiment. Section 4: Number of animals used in the calendar year PURPOSE OF ENTRY: Used to compile data for annual statistics pursuant to Art. 36, para. 3 TSchG and 147 TSchV. Complete one column for each species of animal. Enter the name of the animal species at the top. Genetically modified lines: One column each is to be used for the wild type and one for the summary of genetically modified lines. Cross-cantonal experiments (art. 27 TVV): in experiments that concern several cantons, one column is to be completed for each animal species for each canton. If the same animals were used in several cantons, this must be explicitly mentioned in Section 44. However, each individual should be counted but once. Larvae and embryos (art. 112 c and d TSchV): embryos in the last trimester of the development period before birth or hatching and larva stages that are already ingesting food freely are likewise counted. If they have not yet reached birth or completed the

5 - 5 - metamorphosis at the end of the experiment, they are to be defined as embryos or larvae and reported in a separate column. Every animal that was used in an animal experiment at any time in the reporting year (1 January to 31 December) should be counted once, regardless of whether the animal belongs to the experimental group or is an untreated control animal, eliminated during the experiment etc. If an animal was already used in the same experiment in the previous year (same licence number), it is shown under Section 41, otherwise under Section 42. If animals were used several times for the same or different experiments in the reporting year (different licence numbers), this must also be in Section 44. Otherwise they will be counted as normal species. If more than three columns are needed, complete a further Form C. Section 41: Number of animals taken over from the previous year under this licence number Indicate the number of animals which were used under the same licence number in the previous year and are still in use in the reporting year, i.e. animals which remain in the experiment after the year-change to the reporting year. Examples include chronic toxicity studies or repeated use of rabbits in pyrogen tests (this number corresponds to the number of animals reported in Section 72 in the previous year). Section 42: Number of animals newly used under this licence number in the reporting year State the number of animals newly used in the reporting year. Count animals which were used for the first time for experimental purposes and those which were used in the previous year for a different experiment that has been concluded in the meantime. Section 43: Total number of animals used in the reporting year under this licence number State the total number of animals used in this experiment in the reporting year (total of sections 41 and 42). Section 44: Number of animals used repeatedly in the reporting year under this or another licence number PURPOSE OF ENTRY: Determination of re-use and repeated use as defined in the European Convention on the Protection of Vertebrates used for animal experiments and other scientific purposes (Convention of the Council of Europe 123), resolution of the ad hoc Committee of Experts on the Convention of 27 November 1992: Animals that are used twice or more times during the reporting year in the same experiment or in different experiments although for scientific reasons, different individuals could equally have been used. Examples include the repeated use of primates from the same colony for different pharmacological tests and the testing of different substances for their cardiovascular effect on chronically instrumented dogs. Indicate the number of animals which were used twice or more in the reporting year under this licence or additionally under a different licence.

6 - 6 - Ad Section 44: In the case of re-use or repeated use of animals, indicate, where appropriate, the licence number under which the animals were additionally used PURPOSE OF ENTRY: To verify Article 135, para. 8 TSchV, according to which animals must not be used repeatedly in experiments involving high a level of stress (SG3). In the case of re-use or repeated use of animals, the experiments in which the animals were used must be known. This information is also necessary to ensure that animals used repeatedly in the same reporting year are only counted once. Complete only if multiple use of the animals has been made. State the licence number. Section 5: Origin of the animals used PURPOSE OF ENTRY: Compilation of annual statistics on the origin of the animals pursuant to the European Convention on the Protection of Vertebrates used for experiments and other scientific purposes (Convention of the Council of Europe); Resolution of the ad-hoc Committee of Experts on the Convention of 27 November 1992 (see Art. 64b, APL). The indications of origin concern all the individuals used in the reporting year. The total number of animals in the relevant columns of Sections 51 to 54 must correspond to the number of animals stated in Section 43. The animals listed in Section 41 must be counted in Section 51. Section 51: Number of animals originating from the current experiment (as stated in Section 41) or from an earlier animal experiment that has been completed State the number of animals which were involved in an ongoing experiment at the start of the reporting year (Section 41) or which originate from a previous completed animal experiment. For example, primates from permanent colonies or cattle in the stables of research establishments which were used twice or more often in an experiment must be counted under this section. Section 52: Number of animals originating from a licensed laboratory animal husbandry in Switzerland State the number of animals obtained from a licensed animal unit in Switzerland (art. 122 TSchV) and used for the first time in an experiment. Section 52 applies for lab animals according to the European Convention (RS 0.457, art.21): Mice, rats, hamster, guinea-pigs, rabbits, dogs, cats, primates, quails, including genetically modified lines of these species. Animals originating from Switzerland, but not from a licensed animal unit (working animals, pets or wild animals as defined in art. 122, para. 8, TSchV) are to be counted under Section 54. Section 53: Number of animals obtained from an animal breeding station or dealer abroad State the number of animals which were procured from a foreign breeding station or

7 - 7 - supplier for experimental animals - regardless of whether the station is recognized by the national authorities concerned - and used for the first time in an experiment. Section 53 applies for lab animals according to the European Convention (RS 0.457, art.21): Mice, rats, hamster, guinea-pigs, rabbits, dogs, cats, primates, quails, including genetically modified lines of these species. Ad Section 53: When animals are procured abroad, state the country of origin Complete only if an entry was made under Section 53: State the country of origin. Section 54: Number of animals of other origin respectively: other animal species from those in 52 and 53 Indicate the number of animals which - do not originate from an incomplete or previous animal experiment (cf. Section 51) - or from a licensed animal unit in Switzerland (cf. Section 52) - or from a breeding station or dealer in experimental animals abroad (cf. Section 53). For example, zoo animals and households pets used in clinical studies or studies in working animals or wild animals are to be counted here. Ad Section 54: Describe other origin and state number of animals concerned EXAMPLES: Only complete if an indication has been given in Section 54. The origin must be described for the different species. If the animals originate from different sources, the numbers concerned must be stated separately. Patient animals in field studies. Working animals Wild animals. Section 6: Retrospective degree of severity PURPOSE: Compilation of the annual statistics pursuant to art. 36, TSchG containing the information needed to permit an assessment of compliance with animal welfare legislation. One of the main purposes of the law in relation to animal experiments is to limit the stress on individual animals. The publication of statistical data regarding the stress on the animals will contribute to this purpose and ensure transparent information on animal experiments. After the end of the experiment, the degree of severity will be determined according to the actual (estimated) adverse effects on the individual animals or groups of animals, having regard to any failure of the experiment to run according to plan, i.e. under circumstances which diverge from those stated in the application for the licence. In particular, the retrospective degrees of severity must be stated separately for animals and groups of animals within the experiment (cf. art. 24 TVV). Criteria and notes for the correct classification of animals are set out in two information leaflets of the Federal Veterinary Office ( Einteilung von Tierversuchen nach Schweregraden FVO nos and ).

8 - 8 - Note: The severity grades are entered unchanged as stipulated in the abovementioned FVO information leaflets. Possible adaptations with regard to the dignity (article 3 TSchG) and genetically related stresses (articles 25 and 26 TVV) are currently under discussion, but will not enter into force until the publication of a new set of guidelines on severity grades at the earliest. For animals which are still to be used after the end of the year in the experiment which continues in the following year, the degree of severity of the adverse effects up to that time must be stated. In long-term studies (e.g. lifetime toxicity study), spontaneously deceased animals must be allocated to severity degree 3 (Section 64). If an autopsy shows clearly that death was immediate, causing no heavy constraints, a lower degree will be allocated. If such animals were eliminated by euthanasia in an earlier stage of clinical symptoms, a correspondingly lower degree of severity will be allocated (Section 62 or 63). The sum of the Sections 61 to 64 must correspond to the indication given in Section 43. EXAMPLE: Determination of the oral subchronic toxicity of an agricultural chemical on a dog pursuant to guideline No. 409 of the OECD for the testing of chemicals. Sixteen animals are used in three dose groups and one control group. The animals undergo clinical examination once or twice each day; at intervals of five weeks on two occasions, a blood sample is taken and a catheter inserted into the bladder. The animals in the highest and medium dose group showed medium to medium-severe clinical symptoms, while those in the lower dose group only showed brief symptoms on one occasion and those in the control group no clinical symptoms whatever. This gives the following distribution: No adverse effect --> Sec. 61: 0 animals Degree of severity 1 --> Sec. 62: 8 animals Degree of severity 2 --> Sec. 63: 8 animals Degree of severity 3 --> Sec. 64: 0 animals Section 61: Number of animals without adverse effects (degree of severity 0) Indicate the number of animals for which the interventions and measures that were carried out for experimental purposes did not inflict any pain, suffering or damage, instil fear or impair their general wellbeing. As a general rule, animals used for non-stressful experiments or control animals in which no stressful procedures were carried out are to be counted under this heading. Section 62: Number of animals with degree of severity 1 Indicate the number of animals for which the interventions and measures that were carried out for experimental purposes caused slight, short-term pain or damage or impaired slightly their general wellbeing. For example, temporarily anaesthetized animals for MRI measurements or rabbits immunized without the use of Freund s adjuvant are to be counted under this heading. Section 63: Number of animals with degree of severity 2

9 - 9 - Indicate the number of animals for which the interventions and measures that were carried out for experimental purposes caused moderate, short-term or slight, medium to long-term pain, suffering or damage, instilled short-term moderate fear or a substantial, short to medium-term impairment of general wellbeing. For example animals that had electrodes implanted in the brain or that underwent adrenalectomy are to be counted here. Section 64: Number of animals with degree of severity 3 Indicate the number of animals for which the interventions and measures that were carried out for experimental purposes caused medium to long-term moderate or severe pain, lasting moderate to severe suffering, medium to long-term moderate or severe damage, substantial and lasting fear or substantial and lasting impairment of general wellbeing. For example animals which underwent thoracotomy or ischemia of the brain with subsequent substantial functional disorders and animals which died in severe pain that had not been anticipated are to be counted here. Section 7: Elimination or further use of the animals PURPOSE OF ENTRY: State the number of animals which were still being used in the experiment at the end of the year or which had not been eliminated by euthanasia at the end of the experiment and provide information on the planned further use of these animals. The sum of Sections 71 to 73 must correspond to the figure stated in Section 43, i.e. all the animals used in the reporting year must be listed. Section 71: Animals euthanized or perished during or at the end of the experiment State the number of animals which were no longer alive at the end of the experiment or at the end of the year. Count all animals which were killed at the end of the experiment or eliminated by premature euthanasia because of illness or for other reasons and animals used in experiments with lethal consequences. Section 72: Surviving animals to be used for continuation of the experiment in the next year State the number of live animals which were still being used at the end of the reporting year in the experiment which is scheduled to continue in the next year (under the same licence number). For example, count animals which are used in chronic toxicity studies lasting beyond the beginning of the following year (this number will correspond to the number of animals stated in Section 41 in the next reporting year). Section 73: Surviving animals at the end of the experiment State the number of animals which were alive, were not killed and are no longer to be used under this licence number at the end of the experiment (use in later experiments, released as experimental animals).

10 Ad Section 73: Describe use of surviving animals after completion of the experiment and state the number of animals concerned Complete only if an entry has been made in Section 73. The purpose of use must be described for the different animal species. If the animals were intended for different purposes, state the relevant numbers separately. EXAMPLES: Dogs from a clinical study remain with the animal keepers Zoo animals remain in the zoo Wild animals remain in the wild Cattle or primates from permanent stocks for later use in other animal experiments Working animals that are passed on for regular slaughter after the experiment. Section 8: Assessment of the experiment PURPOSE OF ENTRY: To provide information for the cantonal authorities and the cantonal experimentation committees on the success or failure of the experiments and on their continuation. Section 81: Results achieved with regard to the purpose of the experiment and the gain in knowledge Concise description of the results obtained in the reporting year, with special reference to the purpose of the experiment and the gain in knowledge (interpretation of the results). The further objective must be stated in interim reports (i.e. for projects which are to be continued). Section 82: For toxicological studies: state the number of substances tested, number of animals per substance Complete only if standard tests are conducted as part of the verification of the impact and non-toxicity of pharmaceutical preparations and toxicity tests of other substances and products. State the number of tested substances and number of animals per substance, summarized by substance for which the same number of animals were used in each case. In the event of deviations from the standard values, also state the number of doses and the number of animals in each group. Give reasons for deviations. In the case of licences that comprise more than one standard protocol: additional breakdown of figures by the different standard protocols (see also Toxicity Directive FVO No ). Section 83: Suitability of the method, animal species and number of animals. Any changes in method as agreed on with cantonal authority. Potential in respect of 3R Describe the method used, the species and number of animals (group size) in respect of their suitability for the achievement of the aim of the experiment. State any methodological difficulties and changes in method, including any agreements with the cantonal authorities. Give reasons for changes and explain expectations

11 placed in the changed method. State the development of new methods. Estimate refinement and potential for 3R. Section 84: Special events State any unforeseen events which had an impact on the conduct of the experiment. Examples include illnesses, accidents, technical breakdowns, personnel problems. Indicate any delayed start of the experiment or abandon of the experiment. Section 85: Planned reports and publications State reports and/or publications which have already appeared and are planned. State the authors, title, journal/place of publication and source. Enclose a copy for the authority, where appropriate. Section 9: The undersigned resource manager PURPOSE: The undersigned resource manager (Section 38 of the application) is the responsible holder of the licence. He/she bears responsibility for reporting the animals used in the previous year by the stipulated date (Form C) and confirms by his or her signature that the experiment was conducted by the study director in compliance with Section 39 of the application and that the information is complete and correct. Place and date, name and signature. Final section: Confirmation by the cantonal authority PURPOSE: Confirmation by the cantonal authority that the completeness of the indications given in the report was checked and that the contents appear plausible. Place and date, name and signature. Note: Find the European Convention on the Protection of Vertebrates used for Experiments and other Scientific Purposes and the Resolution of the Ad Hoc Committee of Experts to the Convention of the 27 th November 1992 can be found at