Animal Experimentation Statistics Regulation 2013 - 2013 Tvsv

Original Language Title: Tierversuchsstatistik-Verordnung 2013 – TVSV 2013

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501. Regulation of the Federal Minister for Science and Research on the Statistical Collection of Animal Experiments (Animal Experiments Statistics-Ordinance 2013-TVSV 2013)

On the basis of the Animal Experiments Act 2012 (TVG 2012), BGBl. I No 114/2012, in particular Article 43 thereof, shall be arranged:

Subject matter

§ 1. (1) The purpose of this Regulation is to monitor the implementation of the Animal Experiments Act 2012 and the regulations laid down therein. For this purpose, the data referred to in this Regulation shall be collected and transmitted to the European Commission.

(2) The subject of this Regulation is:

1.

the statistical collection of animal experiments (§ § 2 to 5),

2.

the transmission of general information on the implementation of Directive 2010 /63/EU on the protection of animals used for scientific purposes (Animal Experiments Directive), OJ L 327, 28.3.2010, p. No. 33., to the European Commission (§ 6), and

3.

the collection of exceptions for at least equally painless killing methods granted by the competent authorities pursuant to Section 7 (4) Z 1 TVG 2012 (§ 7).

(3) For the purposes of this Regulation, genetically modified animals shall be considered as "genetically modified animals" (§ 4 Z 3 of the German Genetic Engineering Act, BGBl. No. 510/1994) as well as animals with crossed naturally occurring or induced mutations.

Volume of annual reporting requirements for users

§ 2. (1) For the previous calendar year, users shall have until 1 March each year the in the Annex to the competent authority (§ 2 Z 8 TVG 2012) to be forwarded to the Federal Minister of Justice and/or the Federal Republic of Germany. Send the Federal Minister of Science and Research up to 30 April.

(2) According to paragraph 1, animals in which animal experiments have been carried out in accordance with § 2 Z 1 TVG 2012 are to be recorded.

(3) According to paragraph 1, the following shall not be recorded:

1.

Animals that have been killed because they are supernumerary, unless they are genetically modified animals with an intended and also actually occurring phenotype according to § 2 Z 1 lit. a TVG 2012,

2.

Foetuses and embryos of mammals, as well as

3.

genetically modified offspring resulting from the creation of a new genetically modified line.

Special requirements for the collection of statistical data from animal testing

§ 3. (1) The collection of the data pursuant to § 2 on the use of an animal shall be effected for that calendar year in which the animal test in question ends (Section 11 (1) TVG 2012).

(2) In the case of data collection for an animal, only one option may be selected within a data category.

(3) If the option "Other" is selected, details of the relevant registration are to be provided in the "Notes" section.

Published by the Federal Minister Federal Minister for Science and Research

§ 4. The Federal Minister The Federal Minister of Science and Research has to summarize the data submitted in accordance with § 2 and to publish it in accordance with Section 22 (4) TVG 2012 until 30 June 2012.

Forwarding to the European Commission

§ 5. (1) The Federal Minister The Federal Minister of Science and Research has, in order to forward to the European Commission, the following comments to be added to the data published in accordance with Section 4:

1.

general information on any trend changes observed since the previous reporting period,

2.

information on a significant increase in or decrease in the number of animals in one or all of the said categories of data and a justification,

3.

information on trend changes in the actual severity levels and justification,

4.

-special efforts to implement the principle of prevention, reduction and improvement and its possible impact on statistics,

5.

a further breakdown of the "Other" option, provided that a significant proportion of animals are covered by this option, and

6.

more detailed information on cases of animal testing pursuant to § 4 Z 8 TVG 2012, including information on the type and number of animals, any prior exemptions, the details of the use and the justification.

(2) The Federal Minister The Federal Minister for Science and Research has to submit the data in accordance with paragraph 1 for the first time until 10 November 2015 and thereafter every year until 10 November of the European Commission.

Scope of the five-yearly reporting obligation

§ 6. (1) The Federal Minister According to the following information, the Federal Minister for Science and Research has to collect information on the implementation of the Animal Experiments Directive in relation to the last year of the five-year reporting period and, for the first time, up to the 10 November 2018 and thereafter every five years until 10 November of the European Commission:

1.

general changes to previous reports as regards the implementation of the Animal Experiments Directive;

2.

a description of the procedures of the project assessment (§ 29 TVG 2012) and project approval (§ 26 TVG 2012) and the manner in which the requirements of Articles 38 and 40 of the Animal Experiments Directive are met,

3.

the reference of non-human primates (§ 13 TVG 2012) and the manner in which the requirements of Articles 10 and 28 of the Animal Experiments Directive are met,

4.

a list of the animals which are bred, killed and not used for animal testing, including genetically modified animals, which do not fall under the annual statistics, distinguishing between animals for the creation of genetically modified lines, and animals used to maintain established genetically modified lines, including the offspring of wild types,

5.

the general measures taken to ensure that the principle of prevention, reduction and improvement of approved projects, as well as in the accommodation and care of animals, also in the facilities of breeders, and suppliers, appropriately applied,

6.

a general description of the measures taken to ensure that animal testing is not carried out in duplicate,

7.

the number of active authorized breeders, suppliers and users (§ 16 TVG 2012); information on the provisional and definitive revocation of authorisations of breeders, suppliers and users pursuant to § 17 TVG 2012, stating the reasons for this;

8.

representative information on genotyping, the approximate number of animals used, the animal species used and the methods of genotyping, even if an authorisation is not required in accordance with § 1 para. 2 TVG 2012, where appropriate, indicating the degree of severity, and information on the measures taken to refine these methods, and

9.

About

a)

the regulatory framework for competent authorities, including the number and type of authorities,

b)

Structure and activity of the Federal Animal Experiments Commission (§ 35 TVG 2012),

c)

the minimum requirements in accordance with § § 19 (2) and 27 (1) TVG 2012, including any additional training and training for personnel from other Member States,

d)

the number of projects approved each year, and the number and type of projects covered by a permit for 'several similar projects',

e)

the proportion of the total project authorisations in which the period has been extended in accordance with Article 26 (5) of the TVG 2012 and the circumstances in which they are based,

f)

the functioning of non-technical project summaries, the procedure to ensure that the requirements of Article 31 (2) (2) (1) and (2) TVG 2012 are met, as well as whether the non-technical project summaries provide information to projects selected for a retrospective assessment,

g)

Share and type of projects submitted for a retrospective assessment in addition to the projects for which a retrospective assessment pursuant to § 30 Abs.1 Z 2 and 3 TVG 2012 is binding in the framework of § 26 paragraph 6 Z 4 TVG 2012,

h)

the circumstances under which exceptions were approved in accordance with § 15 (2), § 6 (1) Z 5 and § 25 (2) TVG 2012, and information on the exceptional cases pursuant to § 9 paragraph 2 TVG 2012, in which the re-use of an animal during the reporting period approved following an animal test which considered the actual suffering of the animal to be severe,

i)

the structure and activity of animal welfare bodies,

j)

the revocation of project permits pursuant to § 28 TVG 2012 during the reporting period, stating the reasons therefor, and

k)

the nature of the violations in accordance with § 39 TVG 2012 as well as the legal and administrative measures introduced during the reporting period.

(2) Quantitative and qualitative information on work flows, including the criteria laid down in section 32 (3) TVG 2012, and the proportion of unannounced inspections, are broken down for the entire five-year cycle, broken down by years, and by the Federal Minister of the Federal Republic of Germany, To the Federal Minister for Science and Research of the European Commission.

(3) In accordance with Section 22 (2) of the TVG 2012, breeders, suppliers and users have for the first time until 1 March 2018 and thereafter every five years up to 1 March in relation to the last year of the five-year reporting period the data in accordance with paragraph 1 Z 3 to 6 as well as 8, and to make available to the competent authorities, the competent authorities having to identify the data as far as possible from the data already available.

(4) The competent authorities shall have the responsibility of the Federal Minister, respectively. the Federal Minister for Science and Research for the first time until 1 April 2018 and thereafter every five years until 1 April 2018, in relation to the last year of the five-year reporting period, the data referred to in paragraphs 1 and 2 to 9 as well as (2) to the To be made available.

Exceptions to at least equally painless killing methods

§ 7. (1) The exceptions granted pursuant to § 7 paragraph 4 Z 1 TVG 2012 for at least equally painless killing methods shall be the responsibility of the competent authorities of the Federal Minister of State or of the Federal Republic of Germany. The Federal Minister for Science and Research,

1.

the nature of the killing method,

2.

of the species concerned, and

3.

the relevant explanatory statement

to be submitted annually by 30 April for the previous year.

(2) The Federal Minister The Federal Minister for Science and Research has to submit the data to the European Commission in accordance with the provisions of the first paragraph of paragraph 1 to 10 November each year.

Inforce and external force

§ 8. (1) This Regulation shall enter into force 1. Jänner 2014 in force.

(2) With the expiry of 31 December 2013, the Animal Experiments Statistics Regulation, BGBl, shall enter into force. II No 199/2000, except for force.

Mitterlehner

Annex

Collection of statistical data from animal testing

1. General

The number of animals used in animal experiments shall be broken down according to the following categories of data:

Table 1-Data categories

Animal species (point 2)

Re-use (Item 3)

Birthplace (point 4) 1)

Genetic status (Item 5)

Creation of a new genetically modified line (point 6)

Actual Severity (Item 7)

Uses (point 8)

1) For non-human primates, the data categories "reference source" (point 4a) and "generation" (point 4b) are replaced by the data category "birthplace".

2. Animal species

Table 2-Possible selection fields in the data category "Animal art"

Mice ( Mus musculus )

Rats ( Rattus norvegicus )

Guinea pigs ( Cavia porcellus )

Goldhamster ( Mesocricetus auratus )

Chinese Grey Hamster ( Cricetulus griseus )

Mongolian racing meds ( Meriones unguiculatus )

Other Nager ( Other Rodentia )

Rabbits ( Oryctolagus cuniculus )

Cats ( Felis catus )

Dogs ( Canis familiaris )

Ferrets ( Mustela putorius furo )

Other carnivores (other Carnivora )

Horses, donkeys and intersections ( Equidae )

Pigs ( Sus scrofa domesticus )

Goats ( Capra aegagrus hircus )

Sheep ( Ovis aries )

Bovine animals ( Bos primigenius )

Halbaffen ( Prosimia )

Marmosettes and tamarins (e.g. Callithrix jacchus )

Javanape ( Macaca fascicularis )

Rhesus monkeys ( Macaca mulatta )

Green Meerkats Chlorocebus spp. (as a rule) pygerythrus or sabaeus )

Paviane ( Papio spp. )

Dead-head monkeys (e.g. Saimiri sciureus )

Other types of non-human primates (other types of Ceboidea and Cercopithecoidea )

Apes ( Hominoidea )

Other mammals (other Mammals )

Households ( Gallus gallus domesticus )

Other birds (other Aves )

Reptiles ( Reptilia )

Frogs ( Rana temporaria and Rana pipiens )

Krallenfrösche ( Xenopus laevis and Xenopus tropicalis )

Other Amphibians (other Amphibia )

Zebrafish ( Danio rerio )

Other fish (other Pisces ) 1)

Cephalopods ( Cephalopoda ) 2)

1) Fish are to be counted from the stage where they are able to receive food independently. Zebrafish, which are kept under optimal breeding conditions, should be counted five days after fertilisation. In the case of very small fish species, the counting can be carried out on the basis of estimates.

2) All Cephalopods from the stage in which the animal can independently receive food, under the heading cephalopods ( Cephalopoda ) shall be entered. In the case of very small head foundry types, the counting can take place on the basis of estimated values.

3. Reuse

Table 3-Possible selection fields in the Data category "Rejuvenation"

Reuse 1)

1) A re-use according to § 9 (1) TVG 2012 will be available if other animals which have not been previously used could be used for this animal test. Where animals are re-used, the place of birth shall not be disclosed.

4. Place of Birth

Table 4-Possible selection fields in the data category "birthplace"

Animals born in the EU, in a registered breeding farm 1)

Animals born in the EU, but not in a registered breeding farm 2)

Animals born in the rest of Europe 3)

Animals born in the rest of the world 3)

1) This includes animals born in the establishment of a breeder registered in accordance with Union law.

2) This includes animals which are not born in the establishment of a breeder registered in accordance with Union law, and all the exceptions granted in accordance with Section 15 (2) of the TVG 2012 as well as animals caught in the wild.

3) This includes all animals, whether they have been bred in registered farms or other establishments or not, and animals caught in wild animals.

4a. Non-human primate reference source

Table 4a-Possible selection fields in the data category "Non-human primates-reference source"

Animals born in the EU, in a registered breeding farm

Animals born in the rest of Europe 1)

Animals born in Asia

American-born animals 2)

Animals born in Africa 3)

Animals born in other parts of the world 4)

1) This option also includes animals born in Turkey, Russia and Israel.

2) With this option, animals born in North, Central and South America are included.

3) This option also includes animals born in Mauritius.

4) This option also includes animals born in Australasia. The origin of animals covered by this option shall be communicated to the competent authority in the context of the data transfer.

4b. Non-human primate generation

Table 4b-Possible selection fields in the data category "Non-human primate generation"

F0

F1

F2 or higher

Self-sustaining colony

5. Genetic Status

Table 5-Possible selection fields in the data category "Genetic Status"

Genetically not modified 1)

Genetically modified without pathological phenotype 2)

Genetically modified with pathological phenotype 3)

1) This includes all the animals whose genetic material has not been altered, including genetically modified parent animals, which are used to create a new genetically modified line/genetically modified strain.

2) This includes animals without a pathological phenotype (§ 2 Z 1 lit. a TVG 2012), and

-

animals which have been used to create a new line whose genetic material has been altered but which do not show a pathological phenotype, but also

-

genetically modified animals which have been used in other animal experiments but do not show any pathological phenotype.

3) This includes animals with a pathological phenotype (§ 2 Z 1 lit. a TVG 2012), and

-

animals used for the creation of a new line and showing a pathological phenotype;

-

Animals used for the maintenance of an established line with intended pathological phenotype and which have a phenotype according to § 2 Z 1 lit. a TVG 2012 show as well as

-

Genetically modified animals used in other animal experiments and showing a pathological phenotype.

6. Creation of a new genetically modified line

Table 6-Possible selection fields in the data category "Creation of a new genetically modified line"

Animals used for the creation of new genetically modified lines/strains

7. Actual Severity

Table 7-Possible selection fields in the actual severity data category

No restoration of life function

small (maximum)

Medium

Heavy

8. Use

Table 8-Possible selection fields in the data category "Use purposes"

Basic research 1) (see Table 8.1)

Translational and applied research 2) (see Table 8.2)

Use for regulatory purposes and routine production 3) (see Table 8.3)

Protection of the natural environment in the interest of the health or well-being of humans and animals 4)

Conservation of the species

Higher education or Training for the acquisition, maintenance or improvement of professional skills 5)

Forensic investigations

Conservation of colonies of established genetically modified animals which are not used in other animal experiments 6)

1) Fundamental research shall include fundamental studies, including physiological methods, studies for the further exploration of normal and abnormal structures, the functioning and behaviour of living organisms and the environment (including: fundamental toxicological studies), as well as studies and analyses, which are more likely to understand a better or more accurate understanding of a topic, phenomena or basic laws of nature rather than the specific practical application of the results are aligned.

2) This includes research-oriented toxicology as well as investigations on the preparation of applications for regulatory approval and on the development of methods as well as efficacy tests, which are carried out during the development of a new medical product. are carried out. The studies required for regulatory approval applications as such do not fall below.

3) This includes the use of animals in animal experiments carried out in order to comply with statutory requirements for the manufacture of products/substances and their introduction and maintenance on the market, including safety and safety requirements; and Risk assessments of food and feed; tests of products/substances for which, in the final analysis, no applications for regulatory approval are submitted, provided that these tests have been part of an application for regulatory approval, if a such request would have been made; animals used in the manufacture of products have been used when the manufacturing process provides for regulatory approval.

4) This includes studies on the study and understanding of phenomena such as pollution and biodiversity loss, as well as epidemiological studies on wildlife. Regulatory uses of animals for ecotoxicological purposes are not included.

5) This includes training courses for the acquisition and maintenance of practical technical skills, as provided for in § 19 paragraph 2 TVG 2012.

6) The number of animals needed to establish colonies of genetically modified animals with an intended and actually occurring phenotype in accordance with § 2 Z 1 lit. a TVG 2012. The intended use for which the line is bred does not need to be recorded. Animals which are required for the creation of a new genetically modified line, and animals used in other animal experiments, other than development or breeding projects, shall not be included. Animals used for the creation of a new genetically modified line shall be entered exclusively under "Basic Research or" Translational and Applied Research ".

8.1. Research in the context of basic research

Table 8.1-Possible selection fields in the data category "Basic Research"

Oncology 1)

Cardiovascular system (blood and lymphatic vessels)

Nervous system 2)

Atmation system 3)

Gastrointestinal system, including liver 4)

Musculoskeletal system

Immune system

Urogenital system/reproductive system

Sensual organs (skin, eyes, ears)

Endocrine system/metabolism

Multisystemically 5)

Ethology/Animal Behavior/Animal Biology 6)

Other 7)

1) All studies within the framework of cancer research must be specified irrespective of the target system.

2) This includes neuroscience, peripheral or central nervous system, psychology.

3) This also includes investigations of the nose.

4) This also includes investigations of the tongue.

5) This includes only research where more than one system is of great interest, such as infectious diseases. Cancer research does not fall below that.

6) This includes wild animals as well as animals that live mainly in captivity, so that the species in question can be studied in more detail.

7) This shall cover research which does not relate to any of the above-mentioned organs/systems or which are not specific to the institution/system. animals used for the production and maintenance of pathogens, vectors and neoplasms and for the production of their biological material, as well as animals used for the production of polyclonal antibodies in the context of the translational and , except for the production of monoclonal antibodies in the Aszites method, are to be included in "Basic Research" or "Translational and Applied Research".

8.2. Translational and applied research

Table 8.2-Possible selection fields in the data category "Translational and applied research"

Cancer of the human body 1)

Infectious diseases of man 2)

Cardiovascular disease of the human

Nervous and mental disorders of human beings

Respiratory diseases of man 3)

Gastrointestinal disorders of the human, including liver 4)

Musculoskeletal disorders

Immune diseases of the human

Diseases of the urogenital/reproductive system of the human

Diseases of the human sensory organs (skin, eyes and ears)

Diseases of the endocrine system/the metabolic system of the human

Other human diseases

Animal diseases and diseases

Animal welfare 5)

Disease diagnosis 6)

Herbal diseases

Non-regulatory toxicology and ecotoxicology 7)

1) Any study carried out within the framework of applied research involving cancer of the human being should be recorded here, irrespective of the target system.

2) Any research carried out within the framework of applied research involving human infectious diseases should be recorded here, irrespective of the target system.

3) This also includes examinations of nasal diseases.

4) This also includes studies of tongue diseases.

5) This includes investigations in accordance with § 5 Z 2 lit. c TVG 2012.

6) This also includes animals used for the direct diagnosis of diseases such as rabies and botulism. Animals for use for regulatory purposes are not included.

7) This includes research-oriented toxicology and examinations in the context of applications for regulatory approval and method development. In the context of applications for regulatory approval required studies (preliminary studies, MTD-Maximum Tolerated Dose, dt. The maximum tolerated dose does not fall below it.

8.3. Use for regulatory purposes and routine production by type

Table 8.3-Possible selection fields in the data category "Use for regulatory purposes and routine production by type" 1)

Quality control (including batch safety and potenzion tests) 2) (see Table 8.3.1)

Other efficacy and tolerance tests 3)

Routine production 4) (see Table 8.3.2)

Toxicological and other safety tests 5) (see Table 8.3.3)

1) In the case of the selection of the data category "Use for regulatory purposes and routine production by type", tables 8.3a and 8.3b are also to be completed.

2) In this connection, animals must be recorded for the purpose of testing the purity, stability, efficacy, potency and other parameters for the quality control of the finished product and its constituents and for any other checks carried out during the course of the The manufacturing process for authorisation purposes shall be carried out, used or used in order to comply with any other national or international regulatory requirements or the manufacturer ' s internal operating procedures. , Pyrogenicity tests are also to be recorded here.

3) This includes efficacy tests of biocides and pesticides, as well as tolerance tests of feed additives.

4) In this case, the production of monoclonal antibodies in the ascites process and blood products, including polyclonal antisera, can be detected by recognized methods. The immunization of animals within the framework of the hybridoma technique does not fall below it.

5) This shall cover studies to which a product or substance is subjected to its potential for the induction of dangerous or undesirable effects in humans or animals in the event of intended or abnormal use or in the manufacture or manufacture of such products. to explore its potential or actual presence as a pollutant in the environment.

8.3a. Audits under legislation

Table 8.3a-Possible selection fields in the data category "Examination under legislation" 1)

Rules for medicinal products for human use

Rules for veterinary medicinal products and their residues

Rules for medical devices

Rules for industrial chemicals

Rules for plant protection products

Rules for biocidal products

Rules for food, including materials in contact with food

Rules applicable to feed, including rules on the safety of target animals, workers and the environment

Rules for cosmetic products

Other

1) The statutory regulation shall be indicated in accordance with the main purpose of use provided for.

8.3b. Requirements arising from legislation

Table 8.3b-Possible selection fields in the data category "Requirements due to legislation"

Rules that comply with EU requirements 1)

Rules that only comply with national requirements (EU internal) 2)

Rules that meet EU external requirements 3)

1) This includes national rules that are derived from EU rules, as well as any international requirements that simultaneously meet EU requirements.

2) This option may only be selected if the test is carried out to meet the requirements of one or more Member States, and it is not necessarily the Member State in which the work is carried out.

3) This option has to be chosen if there is no comparable rule for the implementation of the test according to EU requirements.

8.3.1. Quality control (including Batch safety and potenzion tests)

Table 8.3.1-Possible selection fields in the data category " Quality Control (einschl. Batch safety and potenzion tests) "

Batch safety tests

Pyrogenicity tests

Batch potenzies

Other quality controls

8.3.2. Routine production, by product type

Table 8.3.2-Possible selection fields in the data category "Routine Production"

Blood-based products

Monoclonal antibodies

Other

8.3.3. Toxicity and other safety tests, by type of test

Table 8.3.3-Possible selection fields in the data category "Toxicity and other safety tests, according to test types"

Test methods for acute toxicity testing (single dose administration, including limit test) (see Table 8.3.3.1)

Skin irritation/corrosion

Skin sensitisation

Eye irritation/corrosion

Toxicity (repeated dose) 1) (see Table 8.3.3.2)

Carcinogenicity

Genotoxicity

Reproductive toxicity

Developmental toxicity

Neurotoxicity

Kinetics (pharmacokinetics, toxicokinetics, decrease in residues)

Pharmacodynamics (including safety pharmacology)

Phototoxicity

Ecotoxicity (see Table 8.3.3.3)

Safety assessment of food and feed 2)

Safety test for target animals 3)

Other

1) This includes immuno-toxicological studies as well as toxicokinetic studies performed as part of the regulatory toxicity test.

2) This also includes drinking water testing (including studies on the safety of target animals).

3) This includes studies aimed at ensuring that a product intended for a given animal is safe for all animals of this type.

8.3.3.1. Acute and subacute toxicity testing methods

Table 8.3.3.1-Possible selection fields in the data category "Acute and subacute toxicity-Test methods"

LD50, LC50

Other lethal methods

Non-lethal methods

8.3.3.2. Toxicity-with repeated administration

Table 8.3.3.2-Possible selection fields in the data category "Toxicity-in the case of repeated administration"

Up to 28 days

29-90 days

> 90 days

8.3.3.3. Ecotoxicity

Table 8.3.3.3-Possible selection fields in the data category "Ecotoxicity"

Acute toxicity

Chronic toxicity

Reproductive toxicity

Endocrine action

Bioaccumulation

Other