Council Directive 77 /93/EEC of 21 December 1976, which is incorporated into the national legal order by Royal Decree 2071/1993 of 26 November 1993 on protective measures against the introduction and dissemination of the national territory and the European Economic Community of organisms harmful to plants or plant products, as well as for export and transit to third countries, lays down the basis for a protection which is necessary for increase the productivity of agriculture. This contributes to the achievement of one of the main objectives of the common agricultural policy.

The Community plant health system provided for in that Directive was applied in an area without internal frontiers, with the aim of protecting the Member States, their regional and local authorities, as well as the plant growers, against damage caused by the introduction of harmful organisms.

In order to ensure the effective application of the Community plant health system, it is necessary to establish a series of measures to eradicate or, if this is not possible, control of infections caused by harmful organisms from third countries or other areas of the European Union, as well as a system of Community financial contributions to distribute at European Union level the burden of possible risks that could be left to trade arising from the application of the Community plant health system.

Consequently, the purpose of this Royal Decree is to regulate the national programmes for the eradication or control of the harmful organisms referred to in Annex I and II of Royal Decree 2071/1993, which are not yet present in the the Spanish territory or part thereof, as well as those not listed in those Annexes whose presence is unknown to date in the Spanish territory and which are deemed to be an imminent danger to the European Union.

In order to prevent infections caused by harmful organisms from third countries, there should also be a Community financial contribution to enhance the plant health inspection infrastructure of the the external borders of the European Union.

The system should also provide appropriate contributions for certain expenditure related to the specific measures taken by Member States to eradicate or, if this is not possible, to control infections caused by harmful organisms from third countries or from other areas of the European Union and, where possible, repair the damage caused.

The implementation of this contribution system requires the European Commission to be given full information on the possible causes of the introduction of the harmful organisms in question and the verification of the correct application of the (a) the Community plant health system in turn, and in order for the State to be able to comply with this duty, the Autonomous Communities must inform the General Administration of the State of the measures taken and the development of the measures taken. If it is found that the introduction of harmful organisms has been caused by inadequate inspections or examinations, Community legislation on the consequences shall be applicable, without prejudice to the adoption of the certain specific measures.

Therefore, it is necessary to incorporate into national law Directive 97 /3/EC of 20 January amending Directive 77 /93/EEC on protective measures against the introduction into the Community of the organisms harmful to plants or plant products and against their spread within the Community.

This Royal Decree is dictated by the provisions of Article 149.1.13. of the Constitution, which attributes to the State the competence in the field of bases and coordination of the general planning of the activity economic.

In the preparation of this provision, the Autonomous Communities and the sectors concerned have been consulted.

In its virtue, on the proposal of the Minister of Agriculture, Fisheries and Food, after the approval of the Minister of Public Administration, according to the Council of State and after deliberation of the Council of Ministers in its meeting on 12 June 1998,

DISPONGO:

TITLE I

General provisions

Article 1. Object.

This Royal Decree lays down the rules for the elaboration, planning, implementation, coordination, monitoring and evaluation of the national eradication programmes or, if not possible, for the control of the spread of harmful organisms of plants in Spanish territory, which shall be enforced throughout the territory of the State.

Article 2. Scope.

National programmes for the eradication or control of plants harmful to plants referred to in Annexes I and II to Royal Decree 2071/1993 of 26 November 1993 which are not yet established in the territory shall apply. or in a part of it.

Such programmes may also be applied for harmful organisms not listed in Annexes I and II to the said Royal Decree, the presence of which is unknown to date in Spanish territory and which is considered to represent a imminent danger to the European Union as a whole, or to a part of it.

Article 3. Definitions.

In addition to the definitions set out in Article 2 of Royal Decree 2071/1993, for the purposes of this Royal Decree, the following definitions shall apply:

a) Established body: is the one that perpetuates for the foreseeable future within a geographical area after its entry.

(b) Suspected lots or plots: are those in which there are plants, with or without symptoms, which make it possible to suspect the existence of harmful organisms referred to in the previous article and for which there is no officially confirmed an appropriate diagnosis or the existence of the organism has not been officially confirmed.

(c) contaminated lots or plots: are those of which a sample has been obtained on which the presence of the harmful organisms has been diagnosed following the procedure laid down in Chapter I of Title IV of this provision.

(d) Confirmation of existence: the administrative act by which the competent authority declares the existence of a harmful organism known for the first time in the territory of an Autonomous Community, as a preliminary diagnosis made by one of the laboratories referred to in Article 13 (1). This act shall immediately be communicated to the Ministry of Agriculture, Fisheries and Food, who shall in turn inform the bodies responsible for the other Autonomous Communities.

(e) eradication or control programmes: the set of measures for the eradication or, where this is not possible, the control of the harmful organism concerned. Such measures shall eliminate or minimise any risk of the spread of the harmful organisms concerned.

(f) Competent authorities: the Directorate-General for Agricultural Production Health shall be the competent authority for the preparation, planning, coordination and information to the European Commission of the national programmes of eradication or control of the spread of harmful organisms.

The official bodies responsible for the Autonomous Communities shall be responsible for the implementation and development of such programmes in the field of their respective territories.

TITLE II

the National Plant Health Committee

Article 4. Creation and attachment.

The National Committee on Plant Health is constituted as a cooperation body under the responsibility of the Directorate-General for Agricultural Production of the Ministry of Agriculture, Fisheries and Food.

Article 5. Composition.

1. The Committee shall be composed of:

(a) President: the Director-General for Agricultural Production of the Ministry of Agriculture, Fisheries and Food.

b) Vice-President: The Deputy Director-General for Plant Health, who, in the event of vacancy, absence, illness or any other legal cause, shall replace the President.

(c) Vocals: a representative of each of the Autonomous Communities who decide to participate in the Committee.

Once these Vocals are appointed, they will be part of the Committee in full and will act with voice and vote.

The Director-General of Agricultural Production Health shall appoint an official assigned to a position of employment assigned to his/her management centre to act as the Secretary of the Committee, with a minimum level of Head of Service.

2. However, where the President or the National Phytosanitary Committee considers it appropriate, the advice of persons other than the same with recognised scientific qualification may be requested in respect of a particular case, as well as the collaboration of entities, associations or groups whose interests may be affected.

Article 6. Functions.

The National Plant Health Committee shall have the following functions:

(a) To study measures for the eradication or control of harmful organisms subject to national programmes and to inform on a mandatory basis the national programmes for the eradication or control of the spread of organisms harmful.

(b) Follow the development of the situation of the harmful organism which is the subject of these programmes from the data obtained by the competent bodies of the Autonomous Communities in their control and surveillance tasks.

c) Propose relevant measures, in particular, on epidemiological investigation and eradication or control measures.

d) Report on other aspects of national plant protection policy.

e) Report on the proposal of the Minister of Agriculture, Fisheries and Food for the purpose of designating laboratories to harmonize diagnostic methods and techniques, as provided for in Article 13.2.

Article 7. Operation.

1. The National Plant Health Committee shall meet, at least, every quarter and on an extraordinary basis whenever the President deems it appropriate or when requested by a third party of the Vocals.

2. The National Committee on Plant Health may establish its own rules of operation, without prejudice to the application of the provisions of Chapter II of Title II of Law No 30/1992 of 26 November 1992 on the rules of procedure. Legal of Public Administrations and of the Common Administrative Procedure.

3. The functioning of the Committee will be met with the personal and material resources of the Ministry of Agriculture, Fisheries and Food and will not increase the Department's expenditure.

TITLE III

National eradication or control programs

Article 8. Criteria for elaboration.

National eradication or control programmes shall include at least the following:

(a) Description of the epidemiological situation of the harmful organism.

(b) Description and delimitation of the geographical and administrative area in which the programme is to be implemented.

(c) The measures to be taken, in particular, where the inspection and the diagnosis made in accordance with the provisions of the programme are positive. These measures should include all the means necessary for the control of the spread or eradication of the harmful organism, in the light of the knowledge of its epidemiology and of the specific prophylaxis methods.

d) Analysis of expected costs.

e) Planned duration of the program.

(f) Provisions to ensure that the declaration of all suspected or confirmed cases or of all the focus of the harmful organism in the area concerned is mandatory.

g) System of registration of affected holdings.

(h) Control procedures for the programme, and in particular the rules on the movement of plants, plant products and other objects liable to be affected by a given harmful organism and inspection regular of the affected holdings or areas.

i) If necessary, measures to allow the identification of the origin of the plants.

j) If necessary, a definition of the methods of analysis, testing and sampling, according to the harmful organism concerned.

k) Where necessary, the rules establishing adequate compensation for producers, traders or importers.

Article 9. Measures to be taken in the program.

1. The necessary measures to be taken may be, inter alia, the following:

(a) The destruction, disinfection, sterilization or any other treatment officially applied or in compliance with an official request, to:

1. Plants, plant products and other constituent objects of the lot or lots which have been the origin of the introduction of the harmful organism in the area concerned and which have been recognised as being contaminated or which have been recognised as contaminated or may be contaminated.

2. Plants, plant products and other objects recognised as being contaminated or liable to be contaminated by the harmful organism introduced as a result of being grown from plants of the batch or lots concerned or have been situated near plants, plant products or other objects of the said lot or of plants grown from them.

3. The cultivation substrates and the grounds recognised as being contaminated or liable to be contaminated by the harmful organism concerned.

4. The materials of production, conditioning, packaging or storage, storage or conditioning premises, means of transport which have been in contact with plants, plant products and other objects mentioned above or with parts thereof.

(b) The inspections or tests carried out officially or following an official request for the purpose of verifying the presence or importance of contamination by the harmful organism introduced.

(c) the prohibition or restriction of the use of cultivation substrates, cultivable, local areas, as well as of plants, plant products or other objects other than the materials of the batch or lots concerned; those arising from the planting of these, where they are the result of official decisions on the grounds of plant health risks related to the harmful organism introduced.

2. The national eradication or control programme shall include all previous measures taken as a matter of urgency by the responsible official body in order to prevent the establishment of the harmful organism and its spread from the outbreaks. initial.

These ex ante measures may be, inter alia, those referred to in Article 7 (6) or in Article 10 (10) of Royal Decree 2071/1993 and those referred to in paragraph 1 of this Article.

Article 10. Adoption of the programme.

The national programmes for the eradication or control of the spread of harmful organisms will be drawn up by the Directorate-General for Health of Agricultural Production on the basis of the proposals presented by the various Autonomous Communities, after report of the National Phytosanitary Committee.

The Ministry of Agriculture, Fisheries and Food, through the appropriate channel, shall, where appropriate, forward this programme to the European Commission for the purpose of its possible financing.

Article 11. Modification of the programs.

Taking into account the evolution of the epidemiological situation, it may be decided, in accordance with the procedure described in the previous Article, that new initiatives be carried out or that the measures taken or planned the programme is subject to additional requirements or conditions necessary for the achievement of the proposed objectives.

Article 12. Community programmes.

If the European Commission set up a programme for a certain harmful organism for which a previous national programme existed, the European programme will be implemented from the moment it is effective. implementation of the national programme.

In addition, when the Commission, through the established channel, modifies the proposed programme, it must be adopted immediately.

TITLE IV

Running the eradication or control programs

CHAPTER I

Diagnostic-related provisions

Article 13. Official and authorized laboratories.

1. The official laboratories in the field of plant health of the Autonomous Communities and the laboratories authorized for this purpose by the competent bodies of those Communities are the only ones to carry out the laboratory diagnosis by means of the use of the appropriate analytical techniques, of the samples intended for the diagnosis of the harmful organisms covered by the scope of this Royal Decree and which have been obtained in those Autonomous Communities. The abovementioned competent bodies shall send the list of these official and authorised laboratories to the General Subdirectorate for Plant Health.

2. In order to harmonise the methods and techniques of diagnosis to be used by the laboratories referred to in the previous paragraph, the Ministry of Agriculture, Fisheries and Food may designate among the above mentioned laboratories, laboratories of recognised prestige to comply with this function, following a report of the National Plant Health Committee.

3. The analytical results of the samples received in the laboratories referred to in paragraph 2 1 and, where appropriate, 2 of this Article, shall be communicated exclusively to the competent authorities for the purposes of legal measures provided for in this case.

4. The other laboratories involved in the diagnosis of pests or diseases of plants and which have determined the suspicion of the existence of any of the harmful organisms referred to in this Royal Decree, must communicate it immediately to the competent bodies of the Autonomous Communities, who in turn shall forward the information to the General Subdirectorate for Plant Health.

Article 14. Sampling.

1. The collection of the sample shall be carried out, where appropriate, in accordance with the protocols established by the rules in force or in default by the European Plant Protection Organisation (OEPP) and official and authorised laboratories.

2. Given the lack of homogeneity in the distribution in the plants of the harmful organisms which are the object of this Royal Decree and in the absence of tolerances regarding the presence of the same in the plots of production or lots of the plants, Plant products and other objects, as they are plant health quarantine or unknown organisms in the Spanish territory, the collection of samples shall consist of a single specimen representative of the lot or parcel.

Article 15. Diagnostic methods.

The diagnostic methods to be used shall be those officially approved and, failing that, those recommended nationally and internationally or those established by reference laboratories.

Article 16. Involvement of stakeholders.

The analytical expert test shall be performed ex officio prior to notification to the data subject to attend the expert's part, within the time limit specified, in order to carry out the laboratory analysis in a single act.

Article 17. Suspicion and confirmation of the existence of the harmful organism.

1. The existence of harmful organisms referred to in Article 2 of this Royal Decree, the responsible official body, is suspected in the communication of individuals or other official bodies or as a result of official inspections. the Autonomous Community where the suspicion occurs shall verify the presence or importance of the contamination and shall take the precautionary measures necessary to prevent the spread of the harmful organism introduced.

2. Officially confirmed the existence of the harmful organism, it shall be communicated, together with the measures adopted and planned for a future, to the Directorate-General for Health of Agricultural Production, for the purpose of the communication of the existence in Spain of that harmful organism to the European Commission and to the other Member States.

CHAPTER II

Indemnities

Article 18. Right of compensation.

1. The costs of the measures described in Article 9 (1) (a) and (b) shall be indemnified, in whole or in part, when they are made in compliance with an official request, with the exception of current expenditure arising from the operation of the responsible official body concerned.

2. Financial losses, other than loss-making profits, directly linked to one or more of the measures referred to in Article 9 (1) (c), shall also be the subject of compensation, in whole or in

.

CHAPTER III

Financing and Media

Article 19. Community participation in the implementation of the programmes.

1. The Ministry of Agriculture, Fisheries and Food may request financial participation from the European Union in the programmes, where the following requirements are met:

(a) The programme has been notified in accordance with the provisions of Article 15 of Royal Decree 2071/1993.

(b) The harmful organism represents an imminent danger to the European Union as a whole or a part thereof, because of its appearance in an area in which the presence of that organism was unknown until that time, or in which that organism had been eradicated or was on the way to eradication.

(c) The harmful organism has been introduced in this area through lots of plants, plant products or other objects from a third country or other area of the European Union.

2. The competent bodies of the Autonomous Communities shall send to the Directorate-General for Agricultural Production of the Ministry of Agriculture, Fisheries and Food information on the following aspects:

(a) The reference of the notification referred to in paragraph 1 (a) of this Article.

(b) The nature and extent of the occurrence of harmful organisms, as well as their evolution and their modalities of detection.

(c) The identity of the lots referred to in paragraph 1 (c) of this Article, through which the harmful organism has been introduced.

However, when the information regarding the identity of the batches cannot be provided, the alleged sources of occurrence will be indicated and the reasons why the batches could not be identified.

(d) The necessary measures that have been taken or envisaged, for which it seeks to benefit from the financial participation of the European Union, with its implementation schedule.

e) The results obtained and the actual or estimated cost of the committed expenses or to be committed and the part of those who have run or are to be run in charge of public credits allocated by the State for the performance of those same measures as are necessary.

3. Where the detection of the harmful organism has occurred before 30 January 1997, that date shall be considered as the date of detection of the organism, provided that the actual date of detection was not earlier than 1 January 1995.

4. The Autonomous Communities shall forward to the Ministry of Agriculture, Fisheries and Food the cases of harmful organisms referred to in Article 2 of this Royal Decree, the presence of which has been detected after 1 January of this year. 1995.

Article 20. Funding from the Ministry of Agriculture, Fisheries and Food.

1. Within the limits laid down by the appropriations available for such purposes and taking into account the gravity of the danger which the presence of the harmful organism concerned may be presumed to be for the national territory, the Ministry of Agriculture, Fisheries and Food, once discounted, where appropriate, the Community contribution, may be involved in the financing of the eradication or control programmes by up to 50 per 100 of the amount result.

2. The Autonomous Communities shall send to the Ministry of Agriculture, Fisheries and Food information concerning payments made as a result of the implementation of a national eradication or control programme, in accordance with the provisions of the applicable rules.

TITLE V

Responsibility

Article 21. Provision of information.

1. Where the European Union determines that the occurrence of a harmful organism in an area in which it was unknown has its cause in a batch of products of national origin, the competent bodies of each Autonomous Community shall refer the matter to the Directorate-General for Health of Agricultural Production of the Ministry of Agriculture, Fisheries and Food, upon request, all information concerning the following aspects:

a) The origin of the contaminated batches.

(b) Administrative actions taken in relation to them, including the examinations, inspections and controls provided for in Royal Decree 2071/1993.

c) The destination of the remaining batches of identical provenance.

2. The Ministry of Agriculture, Fisheries and Food shall transmit the information described in the previous paragraph and any other information requested from the European Commission.

Both the General Administration of the State and the Autonomous Communities shall cooperate with the plant health experts sent by the European Commission in order to obtain additional information.

Article 22. Return of funds received.

When the information obtained in accordance with the provisions of the preceding article is deducted from the failure to comply with the conditions which led to the grant of financing for the implementation of the programmes, the restitution of funds received.

The obligation to repay these funds will be the responsibility of the public administrations responsible for the non-compliance with these conditions.

Article 23. Rights of third parties.

The rights to reimbursement of expenses and compensation for losses or other damages that may be incurred by the General Administration of the State, the Autonomous Communities and individuals with respect to third parties, including other States Member States, pursuant to national law, Community law or international law, shall be given full access to the European Union with effect from the payment of their financial contribution, in the event of expenses, losses or losses. other damages are covered by such participation.

Article 24. Obligations of individuals.

1. Without prejudice to Article 6 (7) and (8) of Royal Decree 2071/1993, any natural or legal person who has plants, plant products or plantings must communicate to the responsible official bodies any atypical occurrence of harmful organisms or any other abnormality affecting them, as well as providing all information on their plant health status when required by the said organisms.

2. The measures to be taken in the eradication or control programmes shall be implemented by those concerned, following the instructions of the technical officers to be determined by the responsible official body.

The non-execution by those affected by those measures shall result in the subsidiary execution of the measures by the responsible official body, on behalf and at the risk of the person concerned, in accordance with the provisions of Article 98 of the Law 30/1992, dated November 27.

Additional disposition first. Basic character.

The provisions of this Royal Decree shall be of a basic standard, in accordance with the provisions of Article 149.1.13. of the Constitution, which reserves the State competence in the field of bases and coordination of the general planning of economic activity.

Additional provision second. Duty of collaboration.

Without prejudice to the additional provision of Royal Decree 2071/1993, the official bodies responsible for the Autonomous Communities must inform the Directorate-General for Health of the Production of the Agriculture the forecasts necessary for the preparation of the control or eradication programs, as well as the results of their implementation and all the necessary for compliance with this Royal Decree.

Additional provision third. Responsibilities of the Government Delegate.

The mechanisms of direct communication between the General Administration of the State and the Autonomous Communities, provided for in this Royal Decree, should be without prejudice to the powers conferred on the Government by Article 22.2 of Law 6/1997 of 14 April of the Organization and the Functioning of the General Administration of the State.

Single repeal provision. Regulatory repeal.

As many provisions of equal or lower rank are repealed, they are contrary to the provisions of this Royal Decree and, in particular, the Order of 11 March 1982 laying down rules for plant health protection. in the seed potato producing areas, and the Resolution of 12 November 1982, of the Directorate-General for Agricultural Production, on actions to be taken in the fight against the 'nematode of the cyst'.

Final disposition first. Faculty of development.

The Minister of Agriculture, Fisheries and Food is empowered to take the necessary measures to comply with the provisions of this Royal Decree.

Final disposition second. Entry into force.

This Royal Decree shall enter into force on the day following that of its publication in the "Official Gazette of the State".

Given in Madrid to June 12, 1998.

JOHN CARLOS R.

The Minister of Agriculture, Fisheries and Food,

LOYOLA DE PALACIO DEL VALLE-LERSUNDI