Animal Experimentation Statistics Regulation 2013 - 2013 Tvsv

Original Language Title: Tierversuchsstatistik-Verordnung 2013 – TVSV 2013

Read the untranslated law here: http://www.ris.bka.gv.at/Dokumente/BgblAuth/BGBLA_2013_II_501/BGBLA_2013_II_501.html

501 Ordinance of the Federal Minister for science and research on statistical returns in respect of animals (animal experimentation statistics regulation 2013 - 2013 TVSV)

According to the animal experiments Act 2012 (TVG 2012), Federal Law Gazette I no. 114/2012, in particular its article 43, is prescribed:

Subject

§ 1 (1) is the aim of this regulation the monitoring of the implementation of the animal Act of 2012 and the regulations therein. To this end are to collect the data referred to in this regulation and to submit to the European Commission.

(2) the object of this regulation is: 1. statistical returns in respect of animal testing (sections 2 to 5), 2. providing general information on the implementation of Directive 2010/63/EC on the protection of animals used for scientific purposes (animal experimentation directive), OJ No. L 276 of 10 p. 33, to the European Commission (§ 6), and 3. the acquisition of granted by the competent authorities pursuant to § 7 para 4 Z 1 TVG 2012 exceptions for at least as painless methods of killing (§ 7).

(3) genetically modified animals are considered "genetically modified animals" for the purposes of this Regulation (§ 4 Z 3 of the genetic engineering Act, Federal Law Gazette No. 510/1994) as well as animals with crossed a naturally occurring or induced mutations.

Scope of the annual reporting requirements for users

2. (1) users have until March 1st of each year for the preceding calendar year to collect the data listed in the Appendix and electronically to the competent authority (section 2 Z 8 TVG 2012) to submit for transmission to the Minister or the Federal Minister for science and research until April 30.

(2) referred to in paragraph 1 are animals that animal experiments according to § 2 1 TVG 2012 carried Z, to capture.

(3) to paragraph 1 are not to capture: 1. animals that were killed for you surplus are, unless it's genetically altered animals with an intended and actually encountered phenotype according to § 2 No. 1 lit. 2012, 2 fetuses and embryos of mammals, as well as 3 not genetically modified seed, the creation of a new genetically modified line are generated in a TVG.

Special requirements for the collection of statistical data from animal experiments

3. (1) the collection of data pursuant to article 2 on the use of an animal has to be made in which the concerned animal ends for that calendar year (article 11, paragraph 1 TVG 2012).

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

(3) if the option "Other" is selected, then to specify details of the respective entry in the column "Comments".

Publication by the Federal Minister and the Federal Minister for science and research

§ 4. The Federal Minister and the Federal Minister for science and research has to summarize the information provided pursuant to article 2 and to publish TVG until June 30 2012 pursuant to § 22 para 4.

Forwarding to the European Commission

§ 5 (1) the Minister or the Federal Minister for science and research has to forward to the Commission data released pursuant to section 4 to supplement the following comments: 1 General information about any changes in trend, that have been recorded since the previous reporting period, 2. information about a significant increase or decrease of the number of animals in one or all of the data categories and justification , 3. information about trend changes in the actual severity levels and a rationale, 4. Special efforts to implement the principle of prevention, reduction, and refinement and its possible impact on the statistics, 5. a breakdown of the option "Other", provided that a significant proportion of animals falls under this option, as well as 6 more detailed information about cases of animal experiments in accordance with § 4 Z 8 TVG 2012 , with information concerning the type and number of animals to any previous exemptions to the details of the use and the grounds.

(2) the Minister or the Federal Minister for science and research has for the first time until 10 November 2015 and thereafter every year until 10 November the European Commission to submit the data referred to in paragraph 1.

Scope of the five-yearly reporting obligation

6. (1) the Federal Minister and the Federal Minister for science and research according to the following instructions, information on the implementation of the animal experimentation directive, moved into to capture on the last year of the five-year period and for the first time until November 10, 2018 and thereafter every five years until 10 November the European Commission to submit: 1. General changes to previous reports with regard to the implementation of the animal experimentation directive , 2. a description of the procedures of the project evaluation (§ 29 TVG 2012) and project approval (section 26 TVG 2012) and the ways and means of fulfilling the requirements of articles 38 and 40 of the animal experimentation directive, 3. the relation of non-human primates (§ 13 TVG 2012) as well as the manner of compliance with the requirements of articles 10 and 28 of the animal experimentation directive, 4. a collection of animals, which bred , killed and not used for animal experiments are, to distinguish including genetically modified animals not covered by the annual statistics, which is between animals that are used for the creation of genetically modified lines, and animals which are used to maintain established GM lines, including the offspring of wild-type, 5th the General measures taken to ensure that the principle of avoidance , Reduction and enhancement of approved projects as well as appropriately applied for the accommodation and care of animals in facilities of breeders and suppliers, 6 a general description of the measures which have been taken are carried out to ensure that animal testing is not twice, 7 the number of active breeders, suppliers and users authorized (§ 16 TVG 2012); Details of preliminary and final revocation of licenses of breeders, suppliers and users in accordance with section 17 TVG 2012 with an indication of the reasons 8 representative information concerning genotyping, the approximate number of animals used, the used species and the methods for the genotyping of a permit in accordance with § 1 para 2 is TVG 2012 not required, if necessary, with indication of the severity, as well as information on the measures taken to refine these methods as well as 9th info on a) the framework regulation for the competent authorities , including the number and type of these authorities, b) structure and activity of the animal experimentation Commission of the Federal Government (section 35 TVG 2012), c) the minimum requirements in accordance with §§ 19, para. 2 and 27 paragraph 1 TVG 2012 including any additional education and training for personnel from other Member States, d) the number of annually approved projects as well as the number and type of projects covered by a permit for "several similar projects" , e) the share of the total project approvals, where the period referred to in section 26 para 5 2012, renewed TVG and about the circumstances which justify this, f) how of non-technical project summaries, on the procedures which ensure that the requirements of § 31 para 2 1 and 2 TVG are Z 2012 met, as well as about whether the non-technical project summaries contain information about projects , which were selected for a retrospective review, g) proportion and nature of projects, in addition to the projects for a retrospective review in accordance with article 30 ABS. 1 Z 2 and 3 TVG 2012 is binding, for a retrospective evaluation in the context of § 26 para 6 Z 2012 presented 4 TVG, h) the circumstances in which exceptions pursuant to § 15 para 2, § 6 para 1 Nos. 5 and § 25 para 2 TVG 2012 approved , and TVG 2012, approved the re-use of an animal after an animal where the actual suffering of the animal as hard was classified, where during the reporting period details of the exceptional cases referred to in section 9, paragraph 2 was, i) structure and activity of animal welfare bodies, j) revocation of approvals in accordance with § 28 TVG 2012 during the reporting period, stating the reasons for this, as well as k) the nature of the infringements referred to in § 39 TVG 2012 as well as the legal and administrative measures during the reporting period.

(2) quantitative and qualitative information about work processes, including in the context of § 32 para 3 TVG 2012 criteria, and the proportion of unannounced inspections are for the entire five year cycle, broken down by years, to collect and to transmit by the Federal Minister and the Federal Minister for science and research of the European Commission.


(3) breeders, suppliers and users have in accordance with section 22 paragraph 2 TVG 2012 for the first time up to March 1, 2018 and every five years thereafter up to 1 March based on the last year of the five-year period to collect the data referred to in paragraph 1 Z 3 to 6 and 8, and to make available to the competent authorities, where the competent authorities these data as far as possible from existing data to determine have.

(4) the competent authorities purchased every five years the Federal Minister or the Federal Ministry of science and research for the first time by 1 April 2018 and thereafter until April 1, 2018 on the last year of the five-year period to provide the data referred to in paragraph 1 Z 2 to 9 and paragraph 2 available.

Exceptions for at least as painless methods of killing

7. (1) that pursuant to § 7 para 4 Z 1 TVG 2012 granted exceptions for at least as painless methods of killing are 1 the nature of the killing method to present 2 of the concerned species, and 3. the respective grounds each year until 30 April for the previous year by the authorities of the Federal Minister and the Federal Minister for science and research, stating.

(2) the Minister or the Federal Minister for science and research has to transmit the data referred to in paragraph 1 until 10 November each year to the European Commission.

Entry into force and expiry

8. (1) this regulation with 1 January 2014 into force.

(2) with expiry of the 31 December 2013 enters the animal experimentation statistics regulation, Federal Law Gazette II No. 199/2000, override.

Mitterlehner

Plant

Collecting statistical data from animal experiments

1. General

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

 



Table 1 - data categories



Species (point 2)



Reuse (point 3)



Place of birth (item 4) 1)



Genetic status (item 5)



Creating a new genetically modified line (point 6)



Actual severity (item 7)



Purposes (point 8) 1) for non-human primates the data categories "Source" (see point 4a), as well as "Generation" are used in place of the data category "Place of birth" (paragraph 4b).

 

2. animal species

 



Table 2 - possible areas of selection in the data category "Species"



Mice (Mus musculus)



Rats (Rattus norvegicus)



Guinea pig (Cavia porcellus)



Golden Hamster (Mesocricetus auratus)



Chinese grey Hamster (Cricetulus griseus)



Mongolian gerbils (Meriones removal)



Other rodents (other Rodentia)



Rabbit (Oryctolagus cuniculus)



Cats (Felis catus)



Dogs (Canis familiaris)



Ferret (Mustela putorius furo)



Other predators (other Carnivora)



Horses, donkeys and crossbreeds (equidae)



Pigs (SUS scrofa domesticus)



Goats (Capra aegagrus hircus)



Sheep (Ovis aries)



Cattle (BOS Primigenius)



Prosimians (Prosimia)



Marmoset and Tamarin (E.g. Callithrix jacchus)



Javanese monkeys (Macaca fascicularis)



Rhesus Monkey (Macaca mulatta)



Green monkey of Chlorocebus spp. (usually pygerythrus or sabaeus)



Baboons (Papio spp.)



Squirrel monkeys (E.g. Saimiri sciureus)



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



Great apes (hominoids)



Other mammals (other Mammalia)



House chickens (Gallus gallus domesticus)



Other birds (other Aves)



Reptiles (Reptilia)



Frogs (Rana temporaria and Rana mosquito pipiens)



Krallenfrösche (Xenopus laevis and Xenopus tropicalis)



Other amphibians (other AMPHIBIA)



Zebra fish (Danio rerio)



Other fish (other PISCES) 1)



(Cephalopods (were) 2) 1) fish are at the stage in which they themselves can absorb nutrition, to count. Zebra fish that are kept under optimal growing conditions, should be counted five days after fertilization. For very small species, counting can be done on the basis of estimates.

(2) all cephalopods are at the stage in which the animal can automatically absorb nutrition to enter cephalopods (were) under the heading. Very small types of cephalopods count can be based on estimates.

 

3. reuse

 



Table 3 - possible areas of selection in the data category "new use"



Re Verwendung1) 1) a further use in accordance with article 9, paragraph 1 TVG 2012 is if other previously unused animals could be used for this testing. Place of birth is not to give again used animals.

 

4. place of birth

 



Table 4 - possible areas of selection in the data category "Place of birth"



In the EU, in one, born Tiere1 registered breeding operation)



In the EU, but not in one, born Tiere2 registered breeding operation)



Beasts3 born in the rest of Europe)



Beasts3 born in the rest of the world) 1) This includes animals that are born in the operation of a breeder registered under Union law fall.

(2) This includes animals that are born not in operation of a breeder registered under European Union law, and all pursuant to § 15 para 2 fall TVG 2012 granted exceptions and animals captured in the wild.

(3) this fall all animals, regardless of whether they bred in registered farms or other bodies trapped animals were or not, as well as in the wild.

 

4A. Nichtmenschliche primates - source

 



Table 4a - possible areas of selection in the data category "Nichtmenschliche primates - source"



In the EU, a born animals registered breeding operation



Tiere1 born in the rest of Europe)



Animals born in Asia



Tiere2 born in America)



Beasts3 born in Africa)



Tiere4 born in other parts of the world) 1) this option-born animals are also in Turkey, Russia and Israel.

(2) with this option-born animals are in North, Central and South America.

(3) this option includes born animals on Mauritius.

(4) this option includes born animals in Australasia. The origin of the animals, which are covered under this option, is to inform the competent authority in the context of the notification.

 

4B. Nichtmenschliche primates - generation

 



Table 4B - possible areas of selection in the data category "Nichtmenschliche primates - generation"



F0



F1



F2 or higher



Self-sustaining colony 5. genetic status

 



Table 5 - possible areas of selection in the data category "Genetic status"



Genetically not verändert1)



Genetically modified without pathological Phänotyp2)



(Genetically modified with pathological Phänotyp3) 1) This includes all animals, whose Erbgut was unchanged, including not genetically modified parental animals, used for the creation of a new genetically modified line a new genetically modified strain.

(2) This includes animals without pathological phenotype (article 2 subpara 1 lit. a TVG 2012), namely - animals that were used to create a new line whose Erbgut though, changed that show no pathological phenotype, however both - genetically modified animals that were used in other animal studies, but not pathological phenotype show.

(3) This includes animals with pathological phenotype (article 2 subpara 1 lit. a TVG 2012), namely - animals that were used to create a new line and show a pathological phenotype.

-Animals which have been used to maintain an established line with some pathological Phenotype and a phenotype according to § 2 No. 1 lit. a TVG 2012 show and - show genetically altered animals which were used in other animal experiments and a pathological phenotype.

 

6 creating of a new genetically modified line

 



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



Used to create new genetically modified lines/strains animals 7 actual severity

 



Table 7 - possible areas of selection in the data category "Actual severity"



No-recovery



low (maximum)



medium



heavy 8 uses



Table 8 - possible areas of selection in the data category 'Uses'



Grundlagenforschung1) (see table 8.1)



Translational and applied research2) (see table 8.2)



Use for regulatory purposes and Routineproduktion3) (see table 8.3)



Protection of the natural environment in the interests of the health or well-being of people and Tieren4)



Conservation of the species



Education or training to acquire, maintain or improve professional Fähigkeiten5)



Forensic investigations



(Preservation of colonies of established genetically modified animals, not other animals used in werden6) 1) under basic research fall fundamental studies, also physiological kind, studies to further research into normal and abnormal structures, the functioning and the behavior of living organisms and the environment (including fundamental toxicological studies), as well as investigations and analyses, which are more geared to a better or more accurate understanding of a topic, phenomenon, or fundamental law of nature than on the specific practical application of results.


(2) This includes also research-based toxicology, as well as studies on the preparation of applications for regulatory approval and to method development as well as effectiveness checks that are performed during the development of a new medical device. You are not covered for the applications for regulatory approval as such required studies.

(3) this is the use of animals in animal testing performed to meet legal requirements for the manufacture of products/substances and their introduction and conservation on the market, including safety and risk assessment of food and feed; Tests of products/substances, for ultimately no applications for regulatory approval are provided, these tests would have been part of the application for regulatory approval, if such a request would be sent. Animals that were used in the context of the manufacture of products, if the production process provides for a regulatory approval.

(4) This includes studies to the investigation and to the understanding of phenomena such as environmental pollution and Biodiversitätsverluste, as well as epidemiological studies of wild animals. Regulatory uses of animals for eco-toxicological purposes are not covered.

(5) this training to acquire and maintain technical skills, as in § 19 ABS. 2 fall TVG planned 2012.

(6) where the number of animals is to enter, which are needed, to colonies of genetically modified animals of established lines with an intended and actually encountered phenotype according to § 2 No. 1 lit. a 2012 to get TVG. The purpose for which the line is bred, does not need to be captured. Animals that are needed for the creation of a new genetically modified line, as well as animals, that are used in other animals, except development or farming projects, are not covered. Animals that were used for the creation of a new genetically modified line only include "basic research or"translational and applied research"to enter.

 

8.1. investigations in the framework of basic research

 



Table 8.1 - possible areas of selection in the data category "Basic research"



Onkologie1)



Cardiovascular system (blood and lymphatic vessels)



Nervensystem2)



Atmungssystem3)



Gastrointestinal system, including Leber4)



Musculoskeletal System



Immune system



Urogenital system/reproductive system



Sensory organs (skin, eyes, ears)



Endocrine system/metabolism



Multisystemisch5)



Ethology/animal behaviour/Tierbiologie6)



Andere7) 1) all examinations must be specified in the scope of cancer research regardless of the target system.

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

(3) This includes also investigations of the nose.

(4) This includes also investigations of the tongue.

(5) This includes only research involving more than one system of outstanding interest is like as in infectious diseases. Cancer research does not fall below.

(6) This includes both wild animals and animals that live mainly in captivity, so that the particular species can be studied closer.

(7) this research are to capture that does not relate to one of the aforementioned organs/systems or the organ not - / system-specific. Animals that are used for the manufacture and maintenance of pathogens, vectors and neoplasms and the extraction of their biological material, as well as animals that require Polyclonal Antibody in the context of translational and applied research for the production are monoclonal antibodies in the ascites method, except the production to enter under "Basic research" or "translational and applied research".

 

8.2. translational and applied research

 



Table 8.2 - possible areas of selection in the data category "Translational and applied research"



Cancer of the Menschen1)



Infectious diseases of the Menschen2)



Cardiovascular disease of in humans



Nervous and mental disease of in humans



Respiratory diseases of the Menschen3)



Gastrointestinal diseases of in humans, including Leber4)



Musculoskeletal diseases in humans



Autoimmune diseases of in humans



Diseases of the Genitourinary / of the reproductive system of the people



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



Diseases of the endocrine / metabolic system of the people



Other human diseases



Animal diseases and diseases



Rules5)



Krankheitsdiagnose6)



Plant diseases



(Non-regulatory toxicology and Ökotoxikologie7) 1) any investigation should be assessed within the framework of applied research, which relates to cancers of the people, regardless of the target system here.

(2) any investigation should be assessed within the framework of applied research, which relates to infectious diseases of humans, regardless of the target system here.

(3) This includes also tests of nasal diseases.

(4) This includes also tests of tongue diseases.

(5) This includes investigations in accordance with article 5 subpara 2 lit. (c) TVG 2012.

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

(7) This includes research-based toxicology and investigations in the framework of applications for regulatory approval and to the development of the method. Studies required in the context of applications for regulatory approval (preliminary studies, MTD - maximum tolerated dose, or maximum tolerated dose) are not covered.

 

8.3. use for regulatory purposes and routine production according to types

 



Table 8.3 - possible areas of selection in the data category "Used for regulatory purposes and routine production by type"

1)



Quality control (including Chargenunbedenklichkeits - and potency tests) 2) (see table 8.3.1)



Other efficacy and Toleranzprüfungen3)



Routineproduktion4) (see table 8.3.2)



(Toxicity and other Unbedenklichkeitsprüfungen5) (see table 8.3.3) 1) when selecting a data type "Used for regulatory purposes and routine production by type" in any case, the tables are 8.3a and 8.3 b to be completed.

(2) these animals are to gather to test the purity, stability, effectiveness, potency and other parameters for the quality control of the finished product and its components and any other controls, which are used during the manufacturing process for approval purposes, or used any other national or international regulations or the operational procedures of the manufacturer to comply with. Also Pyrogenitätsprüfungen are here.

(3) below, efficacy testing of biocides and pesticides, as well as tolerance checks fall of feed additives.

(4) this is according to recognized methods to capture the production of monoclonal antibodies in the ascites method and blood products including Polyclonal Antisera. The immunization of animals in the framework of the Hybridoma technology isn't among them.

(5) this covers examinations, a product or a substance is subjected to explore its potential to induce dangerous or undesirable effects in humans or animals with intent or abnormal use or production or its potential or actual presence as a pollutant in the environment.

 

8.3a. tests on the basis of legislation

 



Table 8.3a - possible areas of selection in the data category "Tests on the basis of legislation"

1)



Rules for medicinal products for human



Requirements for veterinary medicinal products and their residues



Regulations for medical devices



Regulations for industrial chemicals



Regulations for plant protection products



Regulations for biocidal products



Rules for food, including materials which come into contact with foodstuffs



Requirements for feed, including provisions for the safety of target animals, workers and the environment



Regulations for cosmetic products



Other 1) Regulation is according to the intended main purpose to specify.

 

8.3. requirements of legislation

 



Table 8.3b - possible areas of selection in the data category "Requirements of legislation"



Regulations, the EU supports erfüllen1)



Rules, only national requirements meet the (EU internal) 2)



(Regulations, the EU external conditions treasures3) 1) are also national rules which EU rules are derived, encompasses and comply with any international requirements, at the same time EU requirements.

(2) this option can only be selected when the examination is carried out, to meet the requirements of one or more Member States, where it is not necessarily to the Member State, in which the work carried.

(3) this option must be selected if there is no comparable provision for the conduct of tests according to EU requirements.

 

8.3.1. quality control (including Chargenunbedenklichkeits - and -potency tests)

 




Table 8.3.1 - possible areas of selection in the data category "Quality control (including Chargenunbedenklichkeits - and -potency tests)"



Batch safety testing



Pyrogenitaetspruefungen



Batch potency tests



Other quality controls 8.3.2. routine production, product types

 



Table 8.3.2 – possible areas of selection in the data category "Routine production"



Blood-based products



Monoclonal antibody



Other 8.3.3. toxicity and other safety tests by test type

 



Table 8.3.3 - any check boxes in the data category "Toxicity and other safety tests by test type"



Test methods for the examination of acute toxicity (in single-dose, including limit test) (see table 8.3.3.1)



Skin irritation/corrosion



Skin sensitization



Eye irritation/corrosion



(During repeated dose studies) 1) (see table 8.3.3.2)



Carcinogenicity



Gene toxicity



Reproductive toxicity



Developmental toxicity



Neurotoxicity



Kinetics (pharmacokinetics, toxicokinetics, debris removal)



Pharmacodynamics (including safety pharmacology)



Photo toxicity



Eco-toxicity (see table 8.3.3.3)



The evaluation of the safety of food and Futtermitteln2)



Evaluation of safety for Zieltiere3)



Other 1) This includes also immune toxicological studies and toxicokinetic studies, which are carried out as part of the regulatory toxicity testing.

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

(3) this fall investigations, to ensure that a product intended for a certain animal for all animals of this species is harmless.

 

8.3.3.1 acute and subacute toxicity - testing methods

 



Table 8.3.3.1 - possible areas of selection in the data category "acute and subacute toxicity - testing methods"



LD50, LC50



Other lethal methods



Non lethal methods of 8.3.3.2. - repeated dose toxicity

 



Table 8.3.3.2 - possible areas of selection in the data category "- repeated-dose toxicity"



Up to 28 days



29-90 days



> 90 days 8.3.3.3 ecotoxicity

 



Table 8.3.3.3 - possible areas of selection in the data category "Ecotoxicity"



Acute toxicity



Chronic toxicity



Reproductive toxicity



Endocrine effects



Bio-accumulation



Others