Regulation on the Methods of Preparing and Implementing Risk Assessment Studies About Introduction, Reintroduction and Breeding of Wild Species

THE MINISTRY OF CULTURE 1217 Pursuant to Article 91, and in relation to Article 93 and Article 106 of the Nature Protection Act (Official Gazette 70/05), the Minister of Culture hereby issues the ORDINANCE ON THE METHOD OF PREPARING AND IMPLEMENTING RISK ASSESSMENT STUDIES WITH RESPECT TO INTRODUCTION, REINTRODUCTION AND BREEDING OF WILD TAXA GENERAL PROVISIONS Article 1 (1) This Ordinance establishes the method of preparing and implementing risk assessment studies with respect to introduction of alien wild taxa into nature, reintroduction of vanished indigenous wild taxa into nature and the breeding of alien wild taxa (hereinafter: the Study). (2) This Ordinance also establishes the procedure of granting authorisations for the exceptional introduction of alien wild taxa into nature on the territory of the Republic of Croatia, for reintroduction of vanished indigenous wild taxa, as well as granting authorisations for the breeding of indigenous or alien wild taxa in the Republic of Croatia (hereinafter: introduction, reintroduction and breeding) and the method of procuring the public opinion. (3) This Ordinance does not apply to the introduction or breeding of genetically modified organisms. Article 2 (1) A legal or natural person who intends to introduce alien wild taxa or reintroduce vanished indigenous will taxa (hereinafter: the applicant) shall be obliged to first carry out a risk assessment of the intended project by producing the Study. (2) By way of derogation, for the purpose of additional reintroduction of indigenous wild taxa for which the Ministry, based on a submitted application, determines that it will result in the increase of biological diversity and nature conservation, the Study shall not be required. The additional introduction or additional reintroduction means the addition of individuals of the same taxon to the already existing population in order to ensure its stability. (3) The applicant who intends to breed alien wild taxa shall be obliged to carry out a risk assessment by producing the Study, if the procedure for granting authorisation ascertains the presence of an environmental risk. THE STUDY AND RISK ASSESSMENT Article 3 (1) The introduction and reintroduction means a single or multiple introductions planned in advance (which consist of partial introductions) during a maximum period of five years in the case of introduction and breeding, or a maximum of ten years in the case of reintroduction. (2) The Study shall be produced for each introduction and reintroduction separately, as well as for breeding where necessary, whereby the risk is assessed for each taxonomy category, even lower than species. The assessment shall also be required for individual parts of plants, animals and fungi which are in any way capable of breeding by themselves. (3) By way of derogation, the risk shall not be assessed for each breeding separately, provided that the same applicant is breeding alien wild taxa of the same taxonomy category under the same conditions and at the same location since the start of breeding for a period of five years. (4) In the case of additional introduction or breeding after the period of five years since the first introduction, or additional reintroduction after the period of ten years since the first reintroduction, a new risk assessment shall be carried out on the basis of the initial risk assessment, with supplementary assessment of likely effects which have resulted from the initial introduction, reintroduction or breeding, and with supplements of new scientific and expert knowledge in biology, ecology, invasiveness and other characteristics of the taxon. Article 4 (1) In preparing the Study, risk shall be assessed on the basis of generally known information which may also include the already existing assessments for the same taxonomy category in the same or similar ecological systems at other locations. (2) Ecological systems shall be considered similar if they do not significantly differ in quality and quantity according to their biotic and abiotic features (physical-chemical properties, climatic conditions, present habitat types, flora, fauna, etc.). (3) The risk assessment data used for drafting the Study shall be quantitatively and qualitatively assessed and expressed. (4) The precautionary principle shall be applied to all risk assessments. Article 5 (1) During the preparation and evaluation of the Study, the following shall especially be taken into account: – the purpose of the introduction, reintroduction or breeding – the characteristics and features of the taxon which is being introduced, reintroduced or bred – the features of the ecosystem and habitat into which the taxon is being introduced or reintroduced, and in particular the conservation of its natural state – the effect of introducing the taxon on the habitat itself and on the ecosystem and – the effect of introducing the taxon on the existing taxa in the ecosystem, especially on the protected and strictly protected taxa, and other taxa significant for preserving the integrity of the habitat and the ecosystem. (2) When preparing the Study and assessing the impacts on nature, it shall be necessary to primarily take into account the hazards resulting from: – invasion of the area of indigenous taxa, fight over food, etc. –displacement or endangerment of indigenous taxa, endangerment of their health and/or human health –cross-breeding with domesticated taxa and, in that regard, the potential loss of genetic material and diversity –loss or degradation of the habitat and – other effects which are harmful to nature, human health and biological diversity. (3) ) When preparing the Study and assessing the impacts on nature, it shall be necessary to continually take into account the real and possible, short-term and long-term as well as direct and indirect impacts on nature. Article 6 Contents of the Risk Assessment Study (1) Mandatory contents of the Study are: – the purpose and aim of the introduction, reintroduction or breeding – the description of the used risk assessment methodology – the description of biological and ecological characteristics of the alien wild taxon or the vanished indigenous wild taxon – the description of the ecological system into which the taxon is introduced, reintroduced or bred – the description of the intended introduction, reintroduction or breeding – the assessment of expected impacts on nature and changes in nature – the proposal of measures for the prevention of likely harmful impacts on habitats and ecosystems and the taxa which inhabit them – special notices, instructions and recommendations – the final risk assessment and – the summary of the Study prepared for the general public in order to procure the public opinion. (2) Mandatory annexes to the Study are: – a map displaying the precise location, the individual spatial and geographical features and any specificities of the actual area of introduction, reintroduction or breeding (natural values, ecosystem, habitat and ecologically important areas) as well as the wider impact area – a map of the potential range of the taxon which is introduced, reintroduced or bred – separate annexes which present all results of measurements, graphs, tables and any other documentation which, due to its size or for other reasons, has not been included in the textual part of the Study, and – sources of the data used. (3) The maps referred to in paragraph 2 of this Article shall be drafted in the proportion determined by the Ministry upon submission of the application. Article 7 Description of the used risk assessment methodology The methodology used for risk assessment shall be described in detail, listing the reasons for selecting that methodology and providing an explanation of its advantages, suitability, applicability on the relevant case and the experience of using it in other cases. Article 8 Description of biological and ecological characteristics of the taxon The description of the taxon which is introduced, reintroduced or bred must contain the following: – taxonomic status of the taxon, including the scientific and Croatian name of the species, genus and, where appropriate, the lower taxon (subspecies, variety, form, strain, breed, etc.) and, if there is no Croatian name, only the scientific name is listed – the ecology of the taxon and the niche which it holds within the ecological system – when introduction or breeding is concerned, the information on whether the taxon is on the European or the national black and/or grey list of invasive alien taxa – the area of natural range, specificities of the subspecies or population – when reintroduction is concerned, the historical data on the range and the reasons for the vanishing of the taxon – breeding and propagation method of the taxon – genotype and phenotype characteristics of the taxon, with emphasis on the characteristics which could affect indigenous taxa and habitats, particularly upon introduction, or the dynamics of the ecological system as a whole – description of inter-related impacts between the taxon which is introduced and the already present taxa, particularly of those taxa on which the taxon which is introduced may have a negative impact, and – description of impacts and effects of introduction, reintroduction or breeding of the same taxon in other countries in a similar ecological system. Article 9 Description of the ecological system (1) The description of the ecological system into which the taxon is introduced, reintroduced or the area in which it is bred shall be drafted based on public information obtained from the databases of state and local authorities or other legal persons with public authorities, and on the basis of publicly available, reviewed scientific or expert studies. In the case that there is no public information, it may be prepared by the author of the Study. (2) The description of the ecological system must contain information on: – the precise location of introduction, reintroduction or breeding – climatic, geographical and ecological features and possible specificities – biological diversity with the list of present indigenous plant, animal and fungi taxa and the habitats where impact of the taxa which are introduced, reintroduced or bred is expected – the level of conservation of the ecosystem into which the taxon is introduced, reintroduced or the area in which it is bred – specificities of the ecosystem – natural stability, vulnerability, as well as the capacity for self-regulation and regeneration – the presence and proximity of protected natural values, ecological network and habitats of rare and endangered taxa – the already present alien taxa, including data on their population size and impact on nature – spatial features with the description of the terrain – relief, soil fertility, stability, bearing capacity, hydrologic properties, and – infrastructural equipment and traffic in that area. Article 10 Description of the intended introduction, reintroduction or breeding The description of the intended introduction, reintroduction or breeding must contain information on: – the number or volume of individuals of the wild taxon which will be introduced, reintroduced or bred, their developmental stages and forms, and for animal species also their gender and the age of individuals – the origin of individuals which are introduced, reintroduced or bred – the method of introduction, reintroduction or breeding, including the annual timetable – the planned size of the populating or breeding area – the features of the ecological system which may be affected by introduction, reintroduction or breeding – the size of the wider impact area of introduction, reintroduction or breeding – the results and information on the previous introductions or breeding of taxa in a similar or different ecosystem, if such information exist, and – the constructional and spatial, technical and technological characteristics of the project for the purpose of mitigating or preventing adverse effects. Article 11 Assessment of expected impacts on nature and changes in nature The assessment of expected impacts on nature and changes in nature must list and assess all effects, including those which could be considered unimportant or negligible, and in particular the following: – likelihood of an alien taxon becoming domesticated or invasive in the habitat or the wider ecosystem – likelihood of an alien taxon in any way endangering the populations of the present indigenous wild taxa in the ecological niche which it will likely occupy – likelihood of an alien taxon in any way endangering the populations of the present indigenous wild taxa which are potential food for the existing indigenous or alien taxa – likelihood of the habitats within the introduction area being endangered in any way – likelihood of an alien taxon endangering the existing populations of indigenous wild taxa which are vital for preserving the balance in the ecosystem – likelihood of protected indigenous taxa, endemics and endangered and rare habitat types becoming additionally endangered in any way – possibilities and the need of establishing protective zones in order to prevent any potential spreading of, or negative impacts from, alien taxa – possibilities and the number of adverse impacts and irreversible effects with a financial assessment of potential damages. Article 12 Proposal of measures for the prevention of potential harmful impacts The proposal of measures for the prevention of potential harmful impacts on habitats and ecological systems and the taxa which inhabit them shall contain the following: – types, number and characteristics of alien taxa and the planned management and measures for their use, storage, transport and removal – potential and planned measures which would decrease the possibility of negative impacts on indigenous taxa, habitats and ecosystems – description of damages to nature and the likelihood of damages which could occur, the size of the impact area, the effects on the ecological system and human health as well as potential economic losses, and – required intervention measures for the purpose of mitigating or preventing likely negative effects. Article 13 Special notices, instructions and recommendations Special notices, instructions and recommendations of measures shall be incorporated into the Study if it is established in the risk assessment that the introduction, reintroduction or breeding represents a significant risk to nature. In doing so, it shall be required to list the area where such measures are necessary and to evaluate their suitability. Article 14 Final risk assessment (1) In the final risk assessment the following conclusions may be reached: – that the introduction, reintroduction or breeding will not endanger the natural balance and biological diversity, or – that the introduction, reintroduction or breeding will endanger or alter the natural balance, and endanger and damage biological diversity, or – that the introduction, reintroduction or breeding may alter the natural balance or biological diversity, but the risk to nature is acceptable, expected and surmountable. In this case, the conditions and the scope of introduction, the method of risk control and the protection measures, the method for recovery of potential damages, monitoring and supervision of the taxa and reporting on the results and effects of introduction and breeding shall be determined. (2) If the author of the Study establishes that the significance of introduction, reintroduction or breeding relating to the expected impacts on nature and protection measures could not be completely determined, this shall be stated in the final part of the Study and supported with an explanation. Article 15 (1) The Study shall contain information on its author and on the persons who participated in the preparation of the Study or its parts. (2) The Study and all of its constituent parts shall be certified by the author – natural person or the responsible person of the legal person if the author of the Study is a legal person. GRANTING OF AUTHORISATIONS AND PROCUREMENT OF PUBLIC OPINION Article 16 Submission of the application (1) A legal or natural person planning to introduce, reintroduce or breed shall submit to the Ministry an application for the granting of authorisation. (2) An application shall contain the following information: – the name and address of the legal person, or name, surname and residence address of the natural person who is the applicant – the scientific name of the taxon and Croatian name, if applicable – the purpose of introduction, reintroduction or breeding – the number or volume of individuals of the wild taxon which will be introduced, reintroduced or bred, their developmental stages and forms, and for animal species also their gender and the age of individuals – the origin of individuals – the method of introduction, reintroduction or breeding, including the annual timetable – the description of the breeding location with special emphasis on the limitations which prevent the entry and/or exit of individuals of the same or other species and/or the escape of individuals which are bred, their offspring, breeding cells or any other breeding forms, into the immediate environment, and – the planned size of the area with the precise location of introduction, reintroduction or breeding. (3) An application shall be supplemented with the Study prepared in accordance with the provisions of this Ordinance. The costs of producing the Study shall be defrayed by the applicant. Article 17 (1) If the submitted application is found to be incomplete, the Ministry shall provide the applicant with the deadline for supplementing the application. The deadline shall be set depending on the type of supplement required. If the applicant does not supplement the application within the given deadline, the Ministry shall reject it by virtue of a conclusion, pursuant to the provisions of the Act on General Administrative Procedure. (2) By way of derogation, the Study may be subsequently annexed to the application for breeding in the procedure for granting the authorisation, provided that the Ministry during that procedure ascertains the presence of an environmental risk in accordance with Article 106, paragraph 2 of the Act. In that case, the Ministry shall suspend the procedure and set an appropriate deadline for preparing the Study. If the applicant does not deliver the Study within the given deadline, the Ministry shall refuse the application as incomplete. Article 18 Expert opinion (1) After receiving the application and possible supplements, the Ministry shall without delay submit the application to the State Institute for Nature Protection (hereinafter: the Institute) for the purpose of drafting an expert opinion on the Study. (2) The Institute shall draft the requested opinion within a period of 30 days from the day of receiving the application. Article 19 Granting of authorisations (1) If the Ministry, based on the expert opinion of the Institute, determines that the Study has shortcomings which can be eliminated, it shall request the applicant to eliminate the identified shortcomings within the appropriate deadline. (2) If the applicant does not eliminate the identified shortcomings in the Study within the given deadline, his/her application shall be processed on the basis of the submitted documentation. (3) The supplement to the Study and any other information which is subsequently submitted by the applicant shall be forwarded by the Ministry to the Institute for obtaining an additional opinion. (4) The Ministry, based on the expert opinion of the Institute on the Study and its possible supplements and after the consideration of any comments received in the course of procuring the public opinion which is carried out pursuant to Article 20 of this Ordinance, shall determine the acceptability of the requested introduction, reintroduction or breeding, and shall grant a decision on authorisation or refusal of authorisation to introduce, reintroduce or breed an alien or indigenous wild taxon. The mandatory content of the decision on authorisation shall be the nature protection requirements. (5) The decision on authorising the introduction or reintroduction shall be granted subject to the prior approval of the minister competent for agriculture, forestry, freshwater and sea fisheries and hunting. Article 20 Public inspection (1) In the procedure of granting authorisations for introduction and reintroduction, the Ministry shall obtain the public opinion which is carried out by public inspection of the application and the Study summary published on the official website of the Ministry. (2) In the course of the procedure for obtaining the public opinion, the Ministry shall collect written comments and proposals which may also be submitted by electronic mail. (3) The procedure for obtaining the public opinion shall last 30 days from the day of publishing the application and the Study summary on the official website of the Ministry. Article 21 Register of granted authorisations (1) The Ministry shall keep the register of granted authorisations for introduction, reintroduction or breeding. (2) The Register of granted authorisations shall contain the following information: – class, register number and date of issuing the decision on granting the authorisation – name of the taxon, including the precise taxonomic status – number or volume of individuals which are introduced or bred – precise location of the introduction, reintroduction or breeding – purpose of the introduction, reintroduction or breeding – the name and address of the legal person, or name, surname and residence address of the natural person who is the applicant – the name and address of the author of the Study, and – the period for which the authorisation is granted. (3) The Register shall be kept permanently. (4) The public shall have the right of access to information from the Register. FINAL PROVISION Article 22 This Ordinance shall enter into force on the eighth day after the day of its publication in the Official Gazette. Class: 612-07/07-49/0459 Reg. No: 532-08-01/1-08-4 Zagreb, 26 March 2008 Minister of Culture Božo Biškupić, m.p.