At the Ministry of Interior Ministry of Foreign Affairs at the Ministry of the University 'and Scientific and Technological Research at the Ministry of Defence at the Ministry of Environment at the Ministry of Industry, Commerce and Handicrafts At the Ministry of Foreign Trade at the Ministry of Agriculture, food and Forestry to the Presidents of the pattern of regions and ordinary statute and a special statute to the Presidents of the autonomous provinces of Trento and Bolzano at Ai prefectures of government commissioners of the autonomous regions and provinces at the health departments 'at the regional health departments' provinces for autonomous magnificent rectors of the universities' state to the administrators of Units' local health to the director of the higher Institute of health 'to the directors of experimental zooprophylactic institutes At the regional Federation of veterinarians orders at Italian Trade Union veterinary public medicine Leading the NAS carabinieri Istat At Farmindustria At CNR ENEA the enactment of legislative decree 27 January 1992 n. 116, implementing Directive 86/609 / EEC on the protection of animals used for experimental and other scientific purposes, has profoundly altered the rules of the use of animals in testing. Has introduced such novelties 'highlight a self-control regime that bears any figure of researcher natural or legal person, public or private, of the respect of precise and complex objective and subjective requirements as well as' the limits and conditions established at all stages of use of animals. And on the other hand next to the news' of self must also consider the continuity 'with the repealed law and consistency with the existing criminal laws where it is attributed the character of exceptionality' to the whole system of dispositions that make lawful animal testing. This refers to the limits and under the above conditions out of which, with the exceptions that the law itself provides, you configure the offense of criminal nature. The difficulties' application, linked to numerous innovations of the same legislative decree, have necessitated the enactment of some explanatory circulars, first the n. 32 of 26 August 1992 set up to manage the transitional stage and later, more 'recently, n. 17 and the n. 18 of May 5, 1993, that they intended to provide administrative and operational guidelines relating to Article. 7, for the communication of research projects, and Articles 8 and 9, for derogation licenses. At the same time, necessitating further clarification and practical instructions. It is believed therefore 'appropriate, bring together in this explanatory circular to all that is possible moment in order to arrive at a uniform application of the Legislative Decree n. 116/1992. Scope. Legislative Decree n. 116/1992 regulates all activities 'related to the use of live animals with finalita' experimental and / or scientific, in order to protect their welfare and avoid or minimize any possible pain, suffering, distress, lasting temporary damage that may occur in the during certain experiments. In the discipline of Legislative Decree n. 116/1992 are in evidence: the experimental procedure, the definition of the concept experiment, the animal species that can be used, the origin of the animals. Given that the law and order 'to ensure the animal's well-being, the subject of it and' the attivita ' Experimental as a set of procedures, technologies and professional attitudes that are expressed from breeding, marketing and maintaining the animal's strictly experimental, so give the following results: reduction of the experiments, reducing the number of animals used, reducing the maximum possible suffering. The project and the activities' of research are in the scientific merit entirely independent. Activities 'of research, not all but only those in which' allowed the use of the animal - art. 3, paragraph 1 -, enter the discipline of the law to the reflection that in the choice of the experimental procedure. In any activity 'research is in fact due: 1) demonstrate that is not' can use other methods scientifically validated h and do not involve the use of animals, demonstrating why 'the choice of a particular animal, art. 4, paragraphs 1 and 2; 2) put in place procedures that avoid waste, repetition and suffering for the inadequacy of the model chosen, Articles 6 and 12; 3) work with instruments and appropriate structures to the given procedures, art. 12; 4) exercise self-control with proven preparation for the correct use of the animal is, by the researcher of the different level operators, art. 4, paragraphs 5, 6 and 7, with the preposition of a plant manager with years of experience of animals, Articles 5 and 12, with a permanent medical supervision of a veterinarian doctor what 'responsible, Articles 5, 6 and 12. When the animals used are those protected under art. 2, letter a) of the Decree it constitutes each experiment allowed the animal use with the exception of those expressly provided for practices by the letter d) of Article. 2 and that means ': agricultural practices, such as marking, containment and activities' carried out by the government of the animals, veterinary clinical practice, the least painful methods of killing such as those used to slaughter, the killing and suppression humanitarian animal. Not 'relevant instead to the definition of experiment quantification or qualification of inflicted pain: the sense of pain referred to in subparagraph d) and' too extensive and comprehensive also looking for constituting psychological experiment discriminating criterion. The quantification of pain is instead raised with regard to the general obligation of the animal anesthetic when it is foreseeable at the design stage, or evaluated by the veterinary surgeon in the course of the experiment, that the pain caused by anesthesia and 'greater than that caused experiment. They also are not considered independent experiments those concerning basic research, as fall within the framework of the main experiments which they refer, it 'ones for educational purposes that are particularly subject to prior authorization. three types of establishment are identified: Breeding, supplier and user, for each of which specific obligations are provided. The activities 'experiments can only be carried out at regular authorized user establishments and under the direct responsibility' of the researcher (Art. 4, paragraph 5). animal use. Given the constraint, specified above, preventive search of valid alternatives, all animal species in art. 2, point a), may be the subject of experiment in the respect of specific conditions, however, for some species more 'meaningful, according to the following schedule: a) for all the species that is the fundamental principle for which a function of a specific project a particular species must be the most 'valuable model; b) The second general principle requires that in the context of more 'valid animal model is chosen in the most' low neurological level; c) Dogs, cats, non-human primates and animals in extinction, recognized as such by law, may be the subject of experiment only for limited purposes and with the approval of the Ministry of Health '. All establishments, whether they are breeding, suppliers or users, should guarantee and protect the welfare of animals through the suitability 'of the environments and the proper treatment of the animals at all stages of maintenance and in those of the trial (art. 5 ). Such establishments are subjected to authorization system based on Articles 10, 11 and 12 in the logic to exercise an objective finding of animal welfare as well as the actual number in handling and handling which they are subjected. Animals belonging to the species listed Annex 1 of Legislative Decree must come from farms specifically authorized, as specified in the adjustment to the legislative decree published in the Official Gazette no. 294 of December 15, 1992. About the origin of the animals and rule 'that they come from ellevamenti. Then it remains to be clarified what the discipline that regulates the removal from the environment. Excluding the use of stray animals under Law No. 281/1991, ruled that the levy can be made from the motu proprio from breeding establishments or suppliers and facts, finally, subject to the prohibitions laid down by regional laws, the right 'to use wild animals and' recognized only to the researcher, under article. 4, paragraphs 1 and 2, it can 'demonstrably held that the appropriate single experiment and' a particular species in particular is also wild. They are subject to the prior authorization when wild species are likely to affect non-human primates or those in danger of extinction. The withdrawal from the environment must be subject to communication to the municipality in whose territory it is carried out. A more 'effective protection is given by art. 4, paragraph 1, of Law no. 157 11 February 1992 to certain categories of wild animals for which the levy and 'allowed the permission of the region, only to university scientific institutes, the CNR and the natural history museums for study and research. In this case the rules of the Legislative Decree n. 116/1992 must be combined with the tions of the law I arranged n. 157/1992. In the case of wild species endangered the import authorization or imprisonment for the purposes of art. 3 of Legislative Decree n. 116/1992 granted by the competent bodies also involves the presence of ministerial approval in derogation of Article. 8, letter a) of Legislative Decree n. 116/1992, on presentation of the research project which shows that the species in question and 'the only fit for purpose. The technical standards which establishments must comply are laid down in Annex II to the Legislative Decree n. 116/1992 provided that the latter are not in a specific case not suitable for animal welfare. In this case apply the measures deemed more 'suited under the responsibility' of the plant manager and without prejudice to any other provision of the authority 'control. For species not listed in Annex II shall apply the measures laid down by Law no. 623/1985. In the case of species not listed it 'Annex II it' the law n. 623/1985 shall apply the measures deemed most 'suitable in charge of the establishment, unless otherwise of authority' control. The field trial, notwithstanding art. 12, can 'always be carried out on the basis of a needs' declared and proven art. 4, paragraphs 1 and 2, and art. 7, paragraph 1. In the performance of field trials are still applied art. 3, paragraphs 1, 3, 4 and 5, Article. 4 and art. 6; and 'subject to recourse to the derogation licenses, Articles 8 and 9. Permissions. The granting of licenses to perform the breeding establishment or supplier 'governed by art. 10 which confers jurisdiction to municipalities, while establishments should be authorized by the Ministry of Health ', under Article. 12. And 'possible, in the transitional phase, the continuation of the attivita' to those companies or already 'authorization holders entities granted by the previous legislation or which, on the basis of the same, operate. These subjects are not exempted from complying with the general and specific dictates of Legislative Decree n. 116/1992, the disregard of which entails the application of the sanctions provided by. 14 of the same legislative decree. They also, while continuing in the exercise of 'experimental, must enable the administrative procedures for the regularization of the transition phase. The documentation to be attached to the claim for the user establishment authorization pursuant to art. And 12 'of example in Annex 3. The experiments, depending on the type, are subject to requirements such as simple notification or the request for prior authorization for a derogation for specific cases. Shall also be 'subject to authorization experiments that exceed the maximum duration of three years and are not related to ordinary tests of quality', efficacy and harmlessness' or tests prescribed by the Pharmacopoeia or guidelines or national and international standards (Art. 7, paragraph 2). The interested party must 'submit a special request for the continuation of the trial to the Ministry of Health' one year before the expiry of the three-year period originally fixed. The derogation licenses. They are listed below the different types of tests subject to prior authorization in derogation of the Minister of Health 'in accordance with Articles 8 and 9 of Legislative Decree n. 116/1992: 1) experiments on animals without anesthesia in derogation from art. 4, paragraph 3, which states that all experiments must be carried out under general or local anesthesia, including experiments that involve or are likely to result in serious injury (permanent damage) or severe pain that could continue after the experiment when these are predictable ; 2) experiments on non-human primates, dogs and cats of derogating from the prohibition in Article. 3, paragraph 2; 3) testing of animals in danger of extinction, under Law no. 150 of 7 February 1992 derogating from the prohibition in Article. 3, paragraph 3; 4) experimentation for educational purposes, notwithstanding art. 3, paragraph 1. The aforementioned authorizations shall be granted under strict conditions: the experiment without prior anesthesia and 'only permissible when that' more 'traumatic to the animal experiment itself and when the anesthesia and' incompatible with the end of the experiment, and if the same result or may result in serious injury or severe pain, be granted only in cases of exceptional importance of the experiment; experiments on non-human primates, dogs and cats are allowed for reasons related to the objective of the research, ie must 'relate to medical and biological tests essential sempreche' the use of other animals does not meet the intended purposes; experiments on animals in danger of extinction are eligible exceptionally for essential medical and biological tests when the species in question and 'the only fit for purpose or if the purpose' of research and 'Understanding the conservation of the species concerned; experiments for teaching purposes are allowed only in case of imperative need 'and where it is impossible to use other demonstration systems. Do not fall into this category for those teaching practices that provide demonstrations of animals killed or slaughtered by humane or recognized systems, but also for these cases it is recommended to prefer alternatives demonstration practices when equally related to the objectives that we intend to reach. The experiments of the previous points are permitted only after assessing the procedure and techniques that you intend to use as well as' the end, therefore, the relevant applications should be supported by appropriate technical and scientific documentation. Requests for obtaining the aforementioned authorizations in derogation must be submitted to the Ministry of Health ', accompanied with the relevant research project drawn up in duplicate following the model set out in Annex 4, and when responding to needs that are expected to be of type routine and systematically evaded in a single license. Communication. Under Article. 7, a party wishing to carry out experiments on animals must inform the Ministry of Health ', the region, the prefecture, the town and the united' local healthcare. Communication (v. Annex 4) addressed to the Ministry of Health 'must be accompanied by the declaration, documented ad hoc, that the project' need for research aimed at one of the fine art. 3, paragraph 1, unavoidable in accordance with art. 4 and are insured the conditions provided by art. 5. The use of animals as part of the clinical laboratory diagnostic tests for medical or medical-veterinary fall outside the clinical-veterinary practice and 'subject to the obligation of the single communication to the USL territorial jurisdiction, unless such evidence does not involve cases subject to authorization by way of derogation of articles 4 and 9 of the legislative decree. The Communication, prepared in accordance with art. 4 and signed, it must contain the name, surname, education, residence and social security number of the person responsible for the research project and must be declared the seat of an authorized establishment where you make experiments. The preliminary trials are essential part of the main project must be included in the same communication. The communication should indicate the duration of the project and the names of the staff waiting at execution experiments and / or control of the animal and the veterinary surgeon. E 'is understood that the execution of the experiments or the responsibility' of the same is given to graduates in the disciplines of art. 4, paragraph 5. At present covered only medicine and surgery, veterinary medicine, biology and natural sciences. Communication skills to engage in the activities 'of experimentation, except that it does not provide for derogations, without any act by the Ministry of Health', which can 'ask, if he deems the opportunity', further clarification or to impart specific addresses and prescriptions. The municipalities that receive copies of communications are interested in the powers and responsibilities pertaining to them such as local public bodies in charge of protection of animals and the tasks entrusted to them by the law of 14 August 1991, n. 281, particularly with regard to controls on the use of stray and wild; they may avail themselves of the most representative associations voluntary and expressly qualified and enabled zoophilic guards. the plant manager: duties and responsibilities'. Depending on the type of structure, the number and species stabulate animals and nature of the research, each establishment should make use of qualified staff in sufficient numbers to ensure the welfare and animal control, the adequacy of the equipment and the suitability ' the environment in which they live (articles 4, 5, 10, 11 and 12). Should therefore be identified the person or persons responsible for dealing with the management and organization of the plant in all aspects, both administrative (keeping and updating of the records of loading and unloading as per art. 12, para 3, etc.) , both health and organizational. The responsible person must be qualified and competent and have appropriate knowledge of plant and animal species stabulate needs' resulting from the research protocols that are carried out at the plant. The person or persons responsible must be specifically mentioned in the request for authorization Ministerial. Consistent with the type of structure, the manager employs technical, in adequate numbers, insiders to the care and treatment of animals and the disinfection of environments and maintenance technicians of the plant. E 'by the operator to promote and enable the updating and training of the technical and medical staff. veterinary surgeon. The monitoring of the health status of the animals and health care must be secured by a veterinary surgeon who also performs an advisory role on animal welfare in the different phases, including that of employment (art. 5, art. 6 , paragraph 4; art. 12, para 2). And 'in fact it provided for in Article. 5, paragraph d), that a veterinary surgeon checks the well-being and health of the animals in order to prevent lasting harm, unnecessary suffering and anguish: in this case, the veterinary surgeon can 'be an employee of the structure (producer or user establishment ) or a freelancer veterinarian (with relationship advice) and such control is exercised as part of the general inspection of the test protocol are met when, in the course of the individual tests, the above circumstances (possibility 'of pain, grief, unnecessary suffering or distress). Article. 6, paragraph 4, states that a veterinary surgeon checks the proper execution of the experiment procedures and decide whether the animal shall be kept alive or can. The latter decision requirement and still occurs when, after the experimental procedure, remain or are likely to remain severe pain and suffering. If it does not use such assumptions and the animal and 'kept alive the conditions laid down in Article must be secured. 5 with the same user establishment or by making use of external facilities, including private. In the case of routine and systematic type testing not involving experimental techniques at risk for animal welfare, whose execution and 'made according to established practices of the laboratory, not' need the presence of the veterinarian. Such risk assessment, and 'at the discretion of the veterinarian. registration of animals. The plant manager breeding, supplying or user must write down in a special register, consists of a known number of sheets numbered consecutively, the animals and the related movements. In the case of breeding establishment (Art. 11, paragraph 1) will be noted the number of animals born, died and those supplied, the identification mark (lot number or other small laboratory animals, matriculation or other brand dogs, cats and non-human primates) and species, as well as' dates, and those provided the name and address of the recipient. Establishments will log suppliers well as breeding of origin data. The register initialed autorita 'local, should be stored at the plant for three years at least. In the case of the user establishment in accordance with Article. 12, paragraphs 3 and 4, the register, previously endorsed by the Ministry of Health 'through the offices of the Directorate General of Veterinary Services or veterinary offices for all matters EEC (Annex 1), must be structured so as to be able to follow the fate of each individual animal or batch of animals. It must therefore be provided a section in which is recorded the number of introduced animals, the date, their identification (batch number or other for small laboratory animals, the freshman or other brand for dogs, cats and non-human primates ), the species of all animals as well as' their origin. Section or other distinguished itself must write down the date of use, and the final destiny. Through the registration it must still be possible to follow the phases of use of the animals with their dates within the establishment and, in the case of special field research, even outside. Births that occur in user establishments, only those provided by experimental protocols, must be recorded. If a user establishment uses for experimental animals born in the business as the same outside of the experimental protocols and 'must also be seen as breeding, complying with the provisions of art. 10. Again the records at least three years must be kept available to the authorities' supervisory and control. Report. By 31 March each year, the user establishments must be sent to the Ministry of Health ', Directorate General of Veterinary Services an overall summary report in which the data relating to the use of animals for experimental purposes are indicated in the previous year, and in in particular: a) the number and species of animals used; b) number of animals used, by species and category, in experiments carried out for the purposes of art. 3 and according to the point a), paragraphs 1) and 2), and to the point b); c) number animals used by species and category, and according to the type of test, ranked according to the scheme set out in Annex no. 2. The above data will form an essential basis of the information that must be transmitted to the Commission of the European Communities 'and will be published in the Official Gazette so' as required under Articles 15 and 16 of Legislative Decree. Controls. The controls and inspections user establishments belong to the Ministry of Health 'under Article. 6 of Law no. 833/1978, and the effect of Articles 7, 8, 9, 12 of the Legislative Decree in question. In this capacity, the Ministry carries out all checks and verifications deemed necessary to ensure the correct and uniform application of the decree. The controls on livestock factories and suppliers shall be exercised by the municipality on the basis of art. 10. Supervision. The permanent veterinary supervision of all establishments and 'turning point, according to their competence, by the veterinary services of the united' local health. Minister: GARAVAGLIA