Animal Use Return Guidelines

Transcription

1 Animal Use Return Guidelines The Victorian Department of Economic Development, Jobs, Transport and Resources (DEDJTR), Animal Welfare Victoria Animal Use Return must be completed in addition to an Animal Ethics Committee Annual Report Due Date for submitting Animal Use Return via Themis The Animal Use Return is to be completed in an Excel spreadsheet and must be attached to the Themis Animal Ethics Annual Report Workbench by Monday 4 March Projects for which an Animal Use Return and an AEC Annual Report have not been received by due date may be suspended. Where to find a copy of the Animal Use Return The Animal Use Return (Part A) template must be downloaded from the Themis Animal Ethics Annual Report Workbench. Instruction on how to upload your Animal Use Return in Themis can be found at: Completing the Animal Use Return The details of animal usage in 2018 for every approved AEC project held by a Project Supervisor should be included in a single Animal Use Return. Only include animals used between 1 January 2018 and 31 December Complete the Animal Use Return by filling in each of the columns in the Excel spreadsheet for each project in which animals were used in For a full explanation on how to complete the Animal Use Return please see the following pages. The Animal Use Return is to be completed and uploaded to the Themis Animal Ethics Annual Report Workbench. Appended to this memo is the Animal Welfare Victoria (2018) Animal Use Return Submission Guidelines detailing requirements for three parts of an Animal Use Return; Part A, Part B and Part C. Please note, Primary Contacts need only complete the Part A spreadsheet for their individual Animal Use Return, as instructed above. The below document advises the DEDJTR submission deadline for Animal Use Returns as: 31 March Please note, the Research Ethics and Integrity s internal deadline for Animal Use Returns is 4 March All Annual Reports and associated Animal Use Returns must be submitted by this date. What if.? I used multiple species of animals for the one project in 2018? Projects using multiple species in 2018 will use multiple lines in the Animal Use Return. A separate line of the Return should be used for each species. Two options seem to apply for some columns? Make sure you only enter one number in each cell of the excel spreadsheet. Choose whichever best matches what happens to the cohort being described.

2 I used animals more than once? An animal should be counted in the Return for each project and each year in which it is used. Note that this means the numbers being counted in the Animal Use Return are different from those in the AEC Annual Report (where animals are only counted in the year they are first used). Here are a few examples: A mouse was infected in 2017 and the blood collected in The mouse should be counted in both years in the Animal Use Return (but only in 2017 for the AEC Annual Report) The same animal was used in two different projects, e.g. a cow was used to teach animal handling in two different projects. Count the animal in both projects. We use the same animal in two different protocols in the one project. For instance, as part of the one AEC approved teaching project we teach students to lead a cow and later use the same cow to teach milking. Count the cow once. What is? Column B: Licence Number Designate the licence number (SPPL) under which the Project Supervisor worked. University of Melbourne faculties are assigned the following licence numbers. SPPL Licence name Faculty of Medicine, Dentistry and Health Sciences at Parkville Faculty of Science Faculty of Veterinary and Agricultural Sciences Need more help. Please animal-ethics@unimelb.edu.au

3 ANIMAL USE RETURN SUBMISSIONS GUIDELINE

4 Contents SUBMISSION OF ANNUAL ANIMAL USE RETURN DOCUMENTS The annual return consists of three parts Submitting the return... 3 QUERIES INCLUDING OBTAINING COPIES OF FORMS... 3 ANIMALS TO BE REPORTED IN PART A OF THE RETURN Animal use Animal definition Specified animals Degree of participation in protocols Animals reported in a previous year Animals used in more than one project (repeat use) Animal use outside of Victoria Collaborative projects Specified animal breeding colonies Calculating specified animal breeding colony numbers... 5 DATA ENTRY FOR ANIMAL USE RETURN PART A... 6 Grouping of animals for data entry... 6 Category descriptions and examples... 6 A. Year... 6 B. Licence number... 6 C. Reason for use... 7 D. AEC identification code... 7 E. AEC Approval Date... 7 F. Type of animal in group... 7 G. Source of group... 7 H. Project purpose or specified animal breeding colony group... 7 I. Project benefit or specified animal breeding colony group... 8 J. Particular procedure applied to the group... 8 K. Impact of activities or GM status of specified animal breeding colony group... 8 L. Number of animals in group in M. Number of deaths in the group in APPENDIX 1: CATEGORIES FOR COLUMNS F, G, H, I, J, K, APPENDIX 2 - EXAMPLE OF A COMPLETED PART A, INCLUDING REPORTING OF SPECIFIED ANIMAL BREEDING STOCK PART B: STATEMENTS AND DECLARATION - TO BE COMPLETED BY THE INSTITUTION FOR EACH LICENCE HELD PART C: REPORTING ON PROJECTS INVOLVING DEATH AS AN END POINT Animal Return Submission Guideline 1

5 SUBMISSION OF ANNUAL ANIMAL USE RETURN DOCUMENTS The annual return must be submitted before 31 March 2019 for all scientific procedures premises (SPPL), scientific procedures fieldwork (SPFL), and specified animals breeding (SABL) licenses held for any period during 2018, regardless of whether animals were used or not. Ensure the current five-digit licence number is referenced throughout. Penalties apply for failing to submit an annual return by the due date or providing false or misleading information. Penalty infringement notices and fines may be issued. The licence holder is responsible for the accuracy of information, Animal Welfare Victoria does not undertake an accuracy check prior to accepting the Part B submission as final. 1. The annual return consists of three parts The licence holder is responsible for submitting a complete and accurate return. This may include a Part A and a Part C, but MUST include a Part B. Part A requires details of animals assigned to or used in projects including specified animals within breeding colonies. Part A (an excel spreadsheet) is to be completed only if animals were used for activities under the licence in 2018, including specified animals kept in a breeding colony. Where there are multiple AECs nominated under one licence a separate Part A may be completed for each AEC associated with a licence. The spreadsheet will highlight inconsistent entries, these must be correct prior to submission. Part B incorporates a declaration by the licence holder, summarises animal use under the licence, and details the licence holder s commitment to the principles of replacement, reduction, refinement. One form is to be completed for each licence and must be completed even if animals were not used under the licence in Part C relates to scientific procedures where death is the endpoint. Death as an end point is where the death is a deliberate measure in the procedure and where there will be no intervention to kill the animal humanely before death occurs in the course of the procedure or procedure. These procedures must not be conducted unless approved by the Minister for Agriculture and are undertaken in accordance with any conditions determined by the Minister. Completion of part C (in addition to part A) is required where any procedures where death was the endpoint were conducted under the licence in A separate part C is required for each project involving scientific procedures where death was the end point. Animal Return Submission Guideline 2

6 2. Submitting the return All relevant parts are to be submitted at the same time, and must reference the current five digit licence number. The Part A table must be submitted by: Naming the spreadsheet using licence name, licence number and AEC name Ensuring the name and/or number of the licence is in the subject line ing the spreadsheet as an attachment to: sp.licensing@ecodev.vic.gov.au Electronic copies of the signed Part B form and Part C form (where relevant) may be submitted electronically from: the address of the licence nominee, or from another address ONLY if the licence nominee is copied-in. Originals of signed Part B form and Part C form (where relevant) are only required (by post or direct delivery) when it is not possible to submit these electronically in accordance with the above instruction. QUERIES INCLUDING OBTAINING COPIES OF FORMS These guidelines and Part A, B, and C forms, may be obtained from sp.licensing@ecodev.vic.gov.au or from the forms page at Queries regarding the animal use return should be directed to: Rachel McCarthy Licensing and Audit Animal Welfare Victoria DEDJTR 475 Mickleham Rd ATTWOOD VIC 3049 Ph: sp.licensing@ecodev.vic.gov.au Animal Return Submission Guideline 3

7 ANIMALS TO BE REPORTED IN PART A OF THE RETURN 1. Animal use All animals (see definition below) used under the licence in 2018 must be reported. This includes animals in scientific procedures and breeding colonies of specified animals. AEC approved projects that did not have any animals assigned or used during 2018 are not to be reported in the spreadsheet submitted to the DEDJTR. If disturbance of neonates risks impact to animal welfare, it is acceptable to begin active monitoring at the earliest appropriate time point. For example, for mice, week one may be appropriate. This arrangement must be justified to and approved by the AEC. All animals identified at this time, living and dead, must be counted and recorded under the relevant AEC approval and reported within the annual animal use return. Only animals alive at the time of issue to a project are to be reported. Use (scavenge) of carcasses or tissue from animals acquired after death (for example humanely killed in another reported approved project or for a reason unrelated to activities conducted under the licence) does not require reporting. 2. Animal definition Animal means a live member of a vertebrate species including any fish or amphibian that is capable of self-feeding; or reptile, bird or mammal, other than any human being or any reptile, bird or other mammal that is below the normal midpoint of gestation or incubation for the particular class of reptile, bird or mammal; or a live adult decapod crustacean, that is a lobster; or a crab; or a crayfish; or a live adult cephalopod including an octopus; or a squid; or a cuttlefish; or a nautilus. 3. Specified animals Specified animals are guinea pig; and rat, mouse or rabbit other than a rat, mouse or rabbit bred in the wild; and nonhuman primates. 4. Degree of participation in protocols All animals assigned, issued or used under a project for any period in 2018 must be reported. Where animals were issued to a research or teaching project and determined not suitable and immediately returned to the source it is not necessary to report these animals under the project. Specified animals bred under the licence must be reported under the relevant AEC breeding approval. 5. Animals reported in a previous year An animal must be reported each year in which it is used within a project, regardless of any reporting in previous years. 6. Animals used in more than one project (repeat use) An animal must be reported for each project in which it is used during This may result in an animal being reported more than once if it is assigned to more than one project. Animal Return Submission Guideline 4

8 7. Animal use outside of Victoria Only animals used in Victoria or Victorian waters are to be reported. 8. Collaborative projects To prevent duplication of reporting, animal use must be reported only by the licence under which the AEC approved the animal use. 9. Specified animal breeding colonies Specified animals held or produced for stock maintenance and/or routine breeding under a SABL or SPPL must be reported as specified animal breeding colony animals referencing the relevant AEC approval number. As per the animal definition, report all animals past the half gestation stage of development. 10. Calculating specified animal breeding colony numbers Specified animals that were held or produced under an SABL or SPPL for any period in 2018 must be reported as part of the AEC approved specified animal breeding colony, excluding final progeny distributed for use in another project. These animals are reported under the project and licence that uses them. In summary, the number of animals to be reported for a breeding colony is the sum of: animals present at the start of the year; and animals acquired; and animals born, including neonates humanely killed or found dead minus live animals assigned to AEC-approved projects. Note that specified animals, issued and returned unused must be reported under the relevant breeding colony. Animal Return Submission Guideline 5

9 DATA ENTRY FOR ANIMAL USE RETURN PART A An Excel worksheet is provided to complete Part A of the Return. Where pre-set options are to be used there are dropdown boxes which must be used. Dialogue boxes provide guidance about the information to be entered for each cell. These may be dragged using the mouse if they are obscuring cells. Below the title of column cells is a link to the relevant help section in the help text worksheet. To return to the data entry worksheet, click on the Data entry tag on the left-hand side of the bottom scroll bar. As each line in the worksheet is completed, the entries are tested for internal consistency. When an entry is made that is inconsistent with an entry in an earlier column, it is outlined in red and crossed-through. Pasting of entries may disable the testing macro and internally inconsistent or non-standard entries may occur. Spreadsheets with these incorrect entries will be returned for correction. Grouping of animals for data entry Animals used in scientific procedures are to be reported in groups. A separate line is to be used to describe each group within an approved project. Specified animal breeding colony animals are to be reported in groups by: Animal type; Animal source; and Whether the animals are non-gm or are involved in breeding established GM lines. All other animals used are to be reported in groups by: Animal type; Animal source; Particular procedure; and Impact of different types of procedure on animals (e.g. test group, control group, animals assigned but not used in a procedure etc). Category descriptions and examples Following is a description of the entries for each column of the data entry worksheet. A flow-chart is provided in Appendix 1 to aid completion of the table. The total list of options in the drop-down boxes are in Appendix 2, and a sample completed form is in Appendix 3. A. Year Enter the reporting period year in four-figure format (2018) by using the drop down box. B. Licence number Enter the current, five-digit licence number with the four-letter prefix omitted. For example, for licence SPPL20134 only should be entered. The licence number is found at the top of the relevant licence. Note: many licence numbers changed in 2017, do not reference a previous number. Animal Return Submission Guideline 6

10 C. Reason for use There are two drop down boxes relating to the overall purpose of use: Specified animal breeding colony applies to specified animals held or produced for stock maintenance and/or routine breeding. Where the return relates to a specified animal breeding licence specified animal breeding colony must be selected for all groups. AEC approved project is to be selected for all other animal use. Where the purpose of use is generation of a new line of GM animals the AEC approved project option must be selected. D. AEC identification code The AEC approval reference applied by the AEC to the approval of animal use, including breeding colonies. E. AEC Approval Date The date when the AEC approved, must be written in the format: date/month/year e.g. 12 November 2018 is to be entered as 12/11/2018. This is required for all groups, including specified animal breeding colonies. F. Type of animal in group See appendix 1 for the list of options provided within drop down boxes. Choose the animal type of each group. Note that specified animals are asterisked in the drop-down box. G. Source of group See appendix 1 for the list of options provided within drop down boxes. Choose the appropriate source. For all specified animals, a source marked with an asterisk must be chosen. For non-specified animals, a non-asterisked source must be chosen. H. Project purpose or specified animal breeding colony group See appendix 1 for the list of options provided within drop down boxes. Because this option applies to the project as a whole, it must be identical for all groups that are part of the same project. For specified animal breeding colonies, the specified animal breeding colony option must be chosen. For all other AEC approved projects select the most appropriate option that describes the primary purpose of the project as a whole, or the purpose of the project for which new-line GM animals are being produced. The understanding of human or animal biology : projects that aim to increase the basic understanding of the structure, function and behaviour of animals, including humans, and processes involved in physiology, biochemistry and pathology. Animal Return Submission Guideline 7

11 The maintenance and improvement of human or animal health and welfare : projects that aim to produce improvements in the health and welfare of animals, including humans. Examples Use of a sheep flock to donate blood to produce microbiological media Production of commercial anti-serum, antivenom The improvement of animal management or production : projects that aim to produce improvements in domestic or captive animal management or production. The achievement of education objectives : the purpose of the project is not to acquire new knowledge, rather to pass on established knowledge or training to others. This includes interactive or demonstration classes in methods of animal husbandry, management, examination and treatment. Examples Animals used by veterinary schools to teach examination procedures such as pregnancy diagnosis Sheep used in shearing demonstration classes for students Animals used to teach animal care to TAFE students Environmental objectives : projects that aim to increase the understanding of the animals environment or its role in it, or aim to manage wild or feral populations. These include studies to determine population levels and diversity and may involve techniques such as radio tracking. I. Project benefit or specified animal breeding colony group See appendix 1 for the list of options provided within drop down boxes. Because this option applies to the project as a whole, it must be identical for all groups that are part of the same project. For specified animal breeding colonies, the specified animal breeding colony option must be chosen. For all other AEC approved projects select the most appropriate option that describes the primary purpose of the project as a whole, or the purpose of the project for which new-line GM animals are being produced. J. Particular procedure applied to the group See appendix 1 for the list of options provided within drop down boxes. For specified animal breeding colony animals, the specified animal breeding colony group option must be chosen. For all other AEC approved projects this column describes specific procedures that may have been undertaken on the group. If one of these has been conducted, select that option. If none of these procedures have been used, select the other procedure option. K. Impact of activities or GM status of specified animal breeding colony group See appendix 1 for the list of options provided within drop down boxes. Animal Return Submission Guideline 8

12 For specified animal breeding colony groups select one of the two genetically modified status options for the specified animal breeding colony group. For all other AEC-approved project animals, this describes the impact of any activities on the welfare of the animals in the group. This includes the process of acquiring the animals if stress is likely to be involved (e.g. the capture of wild animals). Select the option reflecting the greatest impact of the procedure carried out on the group. Where an animal dies, the code representing the highest-impact activity that the animal was subjected to prior to death should be chosen. Where an animal is subjected to scientific procedures where death is the end point, that option must always be chosen even when other procedures have been undertaken prior to death. Observation involving minor interference : studies in which the normal activities of animals are minimally impacted on. Examples: Laboratory animals in cages Feeding trial, such as Digestible Energy determination of feed in a balanced diet Behavioural or growth study with minor environmental manipulation Teaching of normal, non-invasive husbandry such as handling, grooming, etc Production of products, such as hormones or drugs, in milk or eggs from genetically modified animals that are subject to normal husbandry procedures only Any of the above where the animal is euthanased at the culmination of its use or as a result of misadventure. Animal unconscious without recovery : the animals are rendered unconscious under controlled circumstances (i.e. not in a field situation) with as little pain or distress as possible. Capture methods are not required. Any pain is minor and brief and does not require analgesia. Procedures are carried out on the unconscious animal that is then killed without regaining consciousness. Examples Animals (including fish) in laboratory killed painlessly for dissection, biochemical analysis, etc Teaching surgical techniques on live, anaesthetised patients that are not allowed to recover following the procedure Minor conscious intervention : the animals are subjected to minor procedures that would normally not require anaesthesia or analgesia. Any pain is minor and analgesia usually unnecessary, although some distress may occur as a result of trapping or handling. Examples Capture and release (with or without tagging) of animals (including fish) in the wild. Excludes electrofishing, refer to Minor Physiological Challenge. Trapping and humane euthanasia for collection of specimens Ear notching (preferred for reduced impact), tail tipping and toe clipping (discouraged on welfare grounds) for identification of new line GM animals Injections, blood sampling in conscious animal Minor dietary or environmental deprivation or manipulation, such as feeding nutrient-deficient diets for short periods Stomach tubing, branding, disbudding, shearing, etc. Animal Return Submission Guideline 9

13 Minor operative procedure with recovery : the animals are rendered unconscious, with as little pain or distress as possible. A minor procedure such as cannulation or skin biopsy is carried out and the animals are allowed to recover (although the animal may later be humanely killed). Depending on the procedure, pain may be minor or moderate and post-operative analgesia may be appropriate. Examples: Biopsies or blood sampling under anaesthesia or sedation Cannulations under anaesthesia or sedation Sedation/anaesthesia for relocation, examination or injections/blood sampling Field capture using chemical restraint methods Minor physiological challenge : the animals remain conscious for some or all of the procedure. There is interference with the animals physiological or psychological processes. The challenge may cause only a small degree of pain/distress or any pain/distress is quickly and effectively alleviated. Examples: Electrofishing Minor infection, minor or moderate phenotypic modification, early oncogenesis Arthritis studies with pain alleviation. Prolonged deficient diets, induction of metabolic disease. Polyclonal antibody production Antiserum production Surgery with recovery : generally, the animals are rendered unconscious, with as little pain or distress as possible. A major procedure such as abdominal or orthopaedic surgery is carried out and the animals are allowed to recover (although the animal may later be humanely killed). Post-operative pain is usually considerable and at a level requiring analgesia. Examples Orthopaedic surgery Abdominal or thoracic surgery Transplant surgery Mulesing, surgical castration without anaesthesia Surgery under anaesthesia for implantation of telemetry tags Moderate to major physiological challenge : the animals remain conscious for some or all of the procedure. There is interference with the animals physiological or psychological processes. The challenge causes a moderate or large degree of pain/distress that is not quickly or effectively alleviated. Examples Major infection, major phenotypic modification, oncogenesis without pain alleviation Arthritis studies with no pain alleviation, uncontrolled metabolic disease Isolation or environmental deprivation for extended periods Monoclonal antibody raising in mice (discouraged alternatives are available) Animal Return Submission Guideline 10

14 Death as an endpoint : See definition on page 2 of this guideline. Do not use this classification to report animals that are humanely killed. Specified animal breeding colony group: non-gm breeding only : routinely bred specified animals with no genetic modification. Specified animal breeding colony group: established GM line breeding : specified animals that have undergone genetic modification (or are from lines of animals resulting from genetic modification). L. Number of animals in group in 2018 Include only animals that are used under the licence. Enter the total number of animals in the group during Where a precise measure of the numbers is impractical, such as for very large groups of animals (e.g. fish schools) or for non-captive animals, an estimate is satisfactory. For specified animal breeding colony groups, this is the sum of: animals at the start of the year; animals acquired; and animals born, minus live animals assigned to other projects. M. Number of deaths in the group in 2018 Enter the number of animals in the group that died or were humanely killed during the reporting period. This includes animals that are euthanased, animals killed for dissection, accidental deaths, death as an endpoint, or death by other causes. To calculate the number of deaths in a specified animals breeding colony, subtract the number of animals alive at the end of the year from the total number of animals reported for the colony. Note that this entry will often generate an error, indicated by being outlined in red and crossed-through. Options chosen that may generate errors in this cell are: Where the options animal unconscious without recovery or death as an end-point are chosen in the impact column (column K), that group must have 100% deaths (ie the same numbers in the number used (column L) and number of deaths columns (column M)). If not all of the animals were killed, those left alive must be described as a separate group in a new line. The number of animals dead with a group may never exceed that used or held. Therefore, the number in column M may never be more than that in column L. Animal Return Submission Guideline 11

15 APPENDIX 1: CATEGORIES FOR COLUMNS F, G, H, I, J, K, Shaded sections indicate choices exclusive to and compulsory for specified animal breeding colony animals Column F. Type of animal in group (* Specified animals) Laboratory Domestic (cont) Reptiles (cont) Native mammals (cont) Ferrets (lab) Other domestic Turtles, tortoises Other native mammals Guinea pigs* (lab) Birds Other reptile Exotic feral mammals Hamsters (lab) Exotic captive Primates Camels (wild) Mice* (lab) Exotic wild Baboons* Cats (wild) Rabbits* (lab) Native captive Macaques* Cattle (wild) Rats* (lab) Native wild Marmosets* Goats (wild) Other laboratory mammal Poultry Primates other* Hares (wild) (not non-human primate) Other birds Native mammal Horses (wild) Domestic mammal Aquatic Dasyurids Mice (wild) Cattle (domestic) Cephalopods Koalas Pigs (wild) Deer (domestic) Crustaceans Macropods Rabbits (wild) Goats (domestic) Fish Native Rats, Mice Rats (wild) Horses (domestic) Amphibia Possums, Gliders Wild dogs and foxes Pigs (domestic) Amphibians Wombats Other exotic feral mammal Sheep (domestic) Reptiles Monotremes Zoo Cats (non-wild) Lizards Seals and sealions Exotic zoo mammal Dogs (non-wild) Snakes Whales and dolphins Column G. Source of group For specified animals (guinea pig; non-wild bred All other animals cont mouse, rat & rabbit; primate) Commercial supplier Own derivation, or Private donation Victoria Specified Animals Breeding Licence, or Municipal pound Interstate institution authorised to distribute Privately owned animals used on a farm specified animals Animals in their natural habitat Imported from overseas Removed from Australian natural habitat Other for the project All other animals Australian captive colony/zoo Own derivation Other source Animal Return Submission Guideline 12

16 Column H. Project purpose or Specified Animal Breeding Colony group Fundamental purpose of project The understanding of human or animal biology Maintenance and improvement of human or animal health and welfare Improvement of animal management or production Project purpose continued The achievement of educational objectives Environmental objectives Specified Animal Breeding Colony (Guinea pig; non-wild bred mouse, rat, rabbit; primate) Specified Animal Breeding Colony group Column I. Project benefit or Specified Animal Breeding Colony group Benefit provided by project Project benefit continued Fundamental biology/physiology organs, tissues or cells from one species to another) Diseases-human Development of techniques- remedial, surgical, Diseases-animal diagnostic Diseases- zoonotic Education (demonstration) Environmental monitoring/ecology Training (student use of animals) Domestic animal management/production Regulatory product testing (e.g. vaccines, chemical, Wildlife management/conservation drug evaluation) Vertebrate pest management Specified Animal Breeding Colony animals only Production of biological products (Guinea pig; non-wild mouse, rat, rabbit; primate) Xenotransplantation (transplantation of living Specified Animal Breeding Colony group Column J. Particular procedure applied to the group Key particular procedures; if not relevant select Other Attachment or insertion of devices for long term direct or telemetric monitoring Aversive stimuli for behavioural training, or for inducing a state of stress integral to the experiment Burning or scalding Induction of other disease model (e.g. diabetes, cardiac disease) Gene manipulative technology Immunomodulatory methods Induction of infection Induction of neoplasia Interference with the central nervous system or sensory capacity or brain centres controlling that capacity Procedure continued In vivo production of monoclonal antibody In vivo production of polyclonal antibody Ionising radiation exposure Neuromuscular blocking agents or electroimmobilisation Ocular irritancy testing Skin irritancy testing involving a chemical, or cosmetic, household, or industrial preparation Toxicity testing Other procedure Specified Animal Breeding Colony animals only (Guinea pig; non-wild mouse, rat, rabbit; i Specified ) Animal Breeding Colony group Animal Return Submission Guideline 13

17 Column K. Impact of activities or GM status of Specified Animal Breeding Colony group Impact of the procedure on the group Observational study involving minor interference Animal unconscious without recovery Minor conscious intervention, no anaesthesia Minor operative procedures with recovery Minor physiological challenge Surgery with recovery Moderate to major physiological challenge Impact of procedure continued Death as an end point - MUST COMPLETE A PART C FORM Specified Animal Breeding Colony animals only (Guineapig; non-wild mouse, rat, rabbit; primate) Specified Animal Breeding Colony group (non-gm) Specified Animal Breeding Colony group established GM line Animal Return Submission Guideline 14

18 APPENDIX 2 - EXAMPLE OF A COMPLETED PART A, INCLUDING REPORTING OF SPECIFIED ANIMAL BREEDING STOCK The following table illustrates how the animal use procedures and the breeding of specified animals is to be reported. The inclusion of group numbers are illustrative only and should not be included in the submitted worksheet. In 2018, under licence SPPL20999, mice and rats (specified animals), and fish were used in Projects and In addition, mice and rats were bred (specified animals) for use under the licence, with corresponding AEC approval. A B C D E F G H I J K L M Year Group Licenc e no Reason for use AEC-approved project AEC identificati on code AEC approval date Type of anima /4/2017 Mice Source Own derivation Purpose of animal use Maintenance human health etc Benefit focus of animal use Diseases human Particular procedure Other procedure Impact on animals Animal unconscious without recovery Total used All deaths Group AEC-approved project /4/2017 Rats Own derivation Maintenance human health etc Diseases human Other procedure Animal unconscious without recovery Group AEC-approved project /4/2017 Rats Own derivation Maintenance human health etc Diseases human Other procedure Observational study etc 10 0 Group AEC-approved project /6/2016 Fish Commercial supplier Understanding biology etc Fundamental biology etc Other procedure Animal unconscious without recovery Group AEC-approved project /6/2016 Fish Commercial supplier Understanding biology etc Fundamental biology etc Other procedure Minor Physiological challenge 5 0 Group AEC-approved project /6/2016 Mice Own derivation Understanding biology etc Fundamental biology etc Other procedure Animal unconscious without recovery 5 5 Group Specified Animal Breeding Colony BC001 1/4/2017 Mice Own derivation Specified Animal Breeding Colony Specified Animal Breeding Colony Specified Animal Breeding Colony Specified Animal Breeding Colony (non-gm) 5, Group Specified Animal Breeding Colony BC001 1/4/2017 Mice Own derivation Specified Animal Breeding Colony Specified Animal Breeding Colony Specified Animal Breeding Colony Specified Animal Breeding Colony established GM line 1, Animal Submission Guideline 15

19 Group Specified Animal Breeding Colony BC003 27/6/2016 Rats Own derivation Specified Animal Breeding Colony Specified Animal Breeding Colony Specified Animal Breeding Colony Specified Animal Breeding Colony established GM line 3, Procedure groups Project was assigned rats and mice, with similar procedures on all the animals. As such, the project was broken down into 2 groups, one for the mice and one for the rats. However, 10 rats were assigned to but did not undergo procedures. A third line was used to describe these animals with zero in the fate column as these rats was carried-over for future procedures under the project (Group 3). Project was assigned laboratory mice and fish, forming 2 initial groups. In addition 19 fish were killed and 5 recovered from minor operative procedures. To describe this variability the fish group was further split into 2, and ultimately the project was described by 3 groups and lines. A zero was entered under the All deaths Column M for group 2, to indicate that no animals died or were killed in this group. Specified animal breeding colony groups The licence bred and used for breeding non-gm mice, and mice and rats from established GM strains: In Column C, Specified Animal Breeding Colony is selected indicating specified animals kept as a general breeding colony for stock animals, rather than animals used in a project involving scientific procedures. Source Column G: Own derivation (specified animals) is entered for all lines. Purpose, Benefit and Particular procedure Columns H, I, and J: Specified Animal Breeding Colony is selected in each. These are the only choices available to breeding stock animals for these columns. Impact column K: One group of mice and the rats produced by SABL301 were breeding from established GM animals. Specified Animal Breeding Colony established GM line has been selected for these. Specified Animal Breeding Colony (non-gm) was selected for the non-gm strain mice group. Total used Column L: numbers entered refer to the breeding-stock animals. Progeny assigned to scientific procedure projects are not included in the Specified Animal Breeding Colony numbers. All deaths Column M: the number of animals culled or died while in the breeding program is indicated for each of the 3 groups (i.e. of the numbers in Column L. This does not include the fate of animals once they have left the breeding colony and are assigned to projects for use in scientific procedures. Animal Submission Guideline 16

20 PART B: STATEMENTS AND DECLARATION - TO BE COMPLETED BY THE INSTITUTION FOR EACH LICENCE HELD Do not submit this Part prior to submitting any required Part A. Reporting period: Licence holder (below box at licence top): Licence designation number (in box at licence top e.g. SPPL20xxx): Licence name (in box at licence top): 1. Summary of activity under the licence in 2018 (a) For each AEC listed for the licence, please provide: i. the number of projects reported in Part A (i.e. NOT spreadsheet lines); ii. the number of new projects that received full approval in 2018 (i.e. NOT provisional approval); iii. the number of applications rejected by the AEC (i.e. NOT returned to the researcher for amendment). Add additional lines as necessary. AEC Name i. Number of projects reported in Part A approved by the AEC ii. Number of new projects approved by the AEC in 2018 iii. Number of new projects rejected by the AEC in 2018 Total (b) Number of projects in which death as an end-point procedures were conducted (death as an end point refers to planned mortality procedures that do not include humane end-points):.. (For each of these projects, the relevant chief investigator must complete Part C). 2. Implementation of institution responsibilities with respect to animal welfare Animal Submission Guideline 17

21 Licence holders have a legal responsibility to implement the principles of Replacement, Reduction and Refinement of animal use in scientific procedures (the 3 Rs - refer to Section 1 of the Australian code). This section is intended to assess the culture and adoption of these principles, so as to provide a state-wide perspective of their implementation. (a) Provide information about training, relevant to animal use under the licence, available to staff and students for procedures on animals, their care and responsibilities under the Australian code including implementation of the 3 Rs. Training provided by the licence holder (institution) in house If yes, provide a brief summary Yes No Access to off-site education provided Yes No If yes, provide a brief summary (b) Provide information about training, relevant to animal use under the licence, available to AEC members including their responsibilities under the Australian code. Training provided by the licence holder (institution) in house If yes, provide a brief summary Yes No Access to off-site education provided Yes No If yes, provide a brief summary (c) What are the institution s recent major achievements that pertain to this licence with regard to the principles of: Replacement Click here to enter text. Reduction Click here to enter text. Refinement of animal use? Click here to enter text. 3. Declaration to be completed by person(s) authorised to sign on behalf of the institution (eg vice chancellor of university or director, chief executive officer and/or secretary of company as appropriate). Add other names if required by the institution. Animal Submission Guideline 18

22 I, Click here to enter text., (person authorised to sign for the institution) being Click here to enter text. (position within the institution) certify that all scientific procedures approved by an Animal Ethics Committee and all specified animal breeding under the licence have been accounted for in the enclosed return, and that all animal usage in all scientific procedures and the specified animal breeding conducted under the licence have been accurately reported in the enclosed return. Date: Click here to enter text. Signature of authorised person:.. Animal Submission Guideline 19

23 PART C: REPORTING ON PROJECTS INVOLVING DEATH AS AN END POINT Part C relates to scientific procedures where death is the endpoint. Death as an end point is where the death is a deliberate measure in the procedure and where there will be no intervention to kill the animal humanely before death occurs in the course of the procedure or procedure. These procedures must not be conducted unless approved by the Minister for Agriculture and are undertaken in accordance with any conditions determined by the Minister. Completion of part C (in addition to part A) is required when any procedures where death was the endpoint were conducted under the licence in A separate part C, in addition to reporting in Part A, is required for each project involving scientific procedures where death was the end point. Reporting period: Institution (below box at licence top): Licence number (in box at licence top): Licence name (in box at licence top): Name of AEC that approved project: AEC identification code: Approval date: Animal Submission Guideline 20

24 1. The species of animal involved. 2. The total number of each species involved in the project. 3. The number of each species that died as a result of the administration of the test agent (chemical or biological). 4. Other comments. Chief Investigator name: Chief Investigator signature: Date: Animal Submission Guideline 21