EUROPEAN PARLIAMENT. Committee on the Environment, Public Health and Consumer Policy

Transcription

1 EUROPEAN PARLIAMT Committee on the Environment, Public Health and Consumer Policy 28 August 2002 PE /45-62 AMDMTS Draft report (PE ) Jonas Sjöstedt on the proposal for a European Parliament and Council regulation on the transboundary movement of genetically modified organisms Proposal for a regulation (COM(2002) 85 C5-0079/ /0046(COD)) Text proposed by the Commission Amendments by Parliament Amendment 45 Recital 3 (3) The Protocol requires each Party to take necessary and appropriate legal, administrative and other measures to implement its obligations under the Protocol. Directive 2001/18/EC of the European Parliament and of the Council of 12 March 2001 on the deliberate release into the environment of genetically modified organisms and repealing Council Directive 90/220/EC, as last amended by Regulation (EC).../... of the European Parliament and of the Council concerning the traceability (3) The Protocol requires each Party to take necessary and appropriate legal, administrative and other measures to implement its obligations under the Protocol. Directive 2001/18/EC of the European Parliament and of the Council of 12 March 2001 on the deliberate release into the environment of genetically modified organisms and repealing Council Directive 90/220/EC invited the Commission to bring forward a legislative proposal for implementing the procedures laid down in the AM\ doc PE /45-62

2 and labelling of genetically modified organisms invited the Commission to bring forward a legislative proposal for implementing the procedures laid down in the Protocol and, in accordance with the Protocol, requiring Community exporters to ensure that all requirements of the Advance Informed Agreement Procedure, as set out in Articles 7 to 10, 12 and 14 of the Protocol, are fulfilled; Protocol and, in accordance with the Protocol, requiring Community exporters to ensure that all requirements of the Advance Informed Agreement Procedure, as set out in Articles 7 to 10, 12 and 14 of the Protocol, are fulfilled; Parliament rejected on 3 July the proposed amendments of Directive 2001/18/EC. The reference to the Regulation (EC).../... of the European Parliament and of the Council concerning the traceability and labelling of genetically modified organisms should therefore be deleted Amendment by Kathleen Van Brempt Amendment 46 Recital 4 (4) It is important to organise the supervision and control of transboundary movements of GMOs in order to take account of conservation and sustainable use of biological diversity, taking also into account risks to human health; (4) It is important to organise the supervision and control of transboundary movements of GMOs in order to take account of conservation and sustainable use of biological diversity, taking also into account risks to human health and the fundamental right of citizens to a free choice in regard to GMOs. PE / /15 AM\ doc

3 In addition to protection of the environment and human health, another principle should also be taken into account in the debate on GMOs - the consumer's right to a free choice. Or. nl Amendment 47 Recital 6 (6) Exports of GMOs should be notified to the country of import, allowing it to make an informed decision, based on risk assessment carried out in a scientifically sound manner; (6) Exports of GMOs should be notified to the country of import, allowing it to make an informed decision, based on risk assessment carried out in a scientifically sound manner and taking into account the precautionary principle; Self-explanatory. Amendment 48 Recital 10 (10) The Protocol provides that Parties may decide to apply either the procedures of the Protocol or their domestic regulations with respect to imports of GMOs. As existing (10) The Protocol provides that Parties may decide to apply either the procedures of the Protocol or their domestic regulations with respect to imports of GMOs. As existing AM\ doc 3/15 PE /45-62

4 Community legislation, and in particular Directive 2001/18/EC and sectoral legislation providing for a specific risk assessment to be carried out in accordance with the principles set out in that Directive, already contain rules which are in line with the objectives of the Protocol, there is no need to adopt supplementary provisions with regard to imports of GMOs into the Community; Community legislation, and in particular Directive 2001/18/EC and sectoral legislation providing for a specific risk assessment to be carried out in accordance with the principles set out in that Directive, already contain rules which are in line with the objectives of the Protocol, the Protocol does not require the Community to adopt additional provisions with regard to imports of GMOs into the Community; The amendment specifies that the Protocol does not require the Community to adopt additinal legislation with regard to imports of GMOs. Whether additional rules are needed is certainly a different question. Amendment 49 CHAPTER 1 Article 3 (5) (b) (b) activities in which GMOs other than micro-organisms are genetically modified or in which such GMOs are cultured, stored, transported, destroyed, disposed of or used in any other way, and for which specific containment measures, based on the same principles of containment as in Directive 90/219/EEC, are used to limit their contact with the general population and the environment. (b) activities involving GMOs other than micro-organisms that are controlled by specific containment measures, based on the same principles of containment as in Directive 90/219/EEC, that effectively limit their contact with, and their impact on, the external environment. PE / /15 AM\ doc

5 The definition in Article 3 (5) b is closer to the definition as foreseen in Article 3 (5) of the Protocol while taking into account the Community framework, in particular Directive 90/219/EEC. Amendment 50 CHAPTER 1 Article 3 (12) (12) "Export" means: (a) the permanent or temporary leaving of the customs territory of the Community of products meeting the conditions of Article 23 (2) of the Treaty, (b) the re-export of products not meeting the conditions referred to in (a) which are placed under a custom procedure other than transit procedure. (12) "Export" means any intentional transboundary movement of genetically modified organisms from the customs territory of the Community to the customs territory of a Party or Non-Party; The Cartagena Protocol does not only apply to transboundary movements of products, i.e. products which have already been placed on the market even though Article 3 (6) of this proposal seems to suggest this by referring to Article 2(7) of Directive 2001/18/EC. It also applies to GMOs which have not yet been made avaibable to third parties. The Commission's definition of export therefore contradicts the Biosafety Protocol which defines export as "intentional transboundary movement from one Party to another Party". AM\ doc 5/15 PE /45-62

6 Amendment 51 CHAPTER 1 Article 3 (12) (a) (new) (12a) "Transboundary movement" means the movement of a genetically modified organism from the customs territory of the Community to the customs territory of a Party or Non-Party The amendment reflects Article 3 (k) of the Biosafety Protocol. While export is the intentional "transboundary movement" of GMOs, the latter term is simply the movement from the Community to another Party. Amendment 52 CHAPTER 1 Article 3 (13) (13) "Import" means the placing under a customs procedure other than transit procedure of products introduced into the customs territory of the Community; (13) "Import" means any intentional transboundary movement into the customs territory of another Party, a Non-Party or of the Community for purposes other than transit; PE / /15 AM\ doc

7 Even though the definition suggests otherwise, the Commission's proposal uses the term "import" in an extremely inconsistent way. In fact, the proposal uses the term in most cases as to mean import into the customs territory of another Party or Non-Party. In a few cases, however, the proposal uses the term as to mean import into the customs territory of the Community (see Art. 11 (2) i). The Commission's definition is also limited to "products" although the protocol does not only apply to GMOs which have already been made available to third parties. Amendment by Torben Lund Amendment 53 CHAPTER II Article 4 (1) 1. The exporter shall ensure notification, in writing, to the competent national authority of the Party or non-party of Import prior to the first intentional transboundary movement of a GMO intended for deliberate release into their environment. The notification shall contain, at a minimum, the information specified in Annex I. The notifier shall ensure that the information contained in the notification is accurate. 1. No first intentional transboundary movement of a GMO intended directly or indirectly for deliberate release into the environment shall take place without the prior written consent of the Party or non- Party of import. The exporter shall ensure notification to the competent national authority of the Party or non-party of Import prior to the first intentional transboundary movement of a GMO intended directly or indirectly for deliberate release into their environment. The notification shall contain, at a minimum, the information specified in Annex I. The exporter shall ensure that the information contained in the notification is accurate. A failure by the Party or non- Party of import to acknowledge receipt of a notification shall not imply its consent to AM\ doc 7/15 PE /45-62

8 an intentional transboundary movement. The Party or non-party of import may, after consenting to the first or additional movements, give notice in writing that written notification of future transboundary movements of the relevant GMO will no longer be required. An addition to the rapporteur's amendment 19 to the effect that the importer shall give consent in writing not only the first time there is an intentional transboundary movement of a GMO but also on each separate occasion. There is a great deal of difference between the consequences of transboundary movements of a few GMOs and the free movement of an unlimited number of GMOs. The Party of import should therefore be able to require written notification of transboundary movements of a GMO until the Party of import decides that written notification of future movements of the relevant GMO is no longer required. This also enables the Party of import to monitor the extent of movements of GMOs for release into its environment. Or. da Amendment by Torben Lund Amendment 54 CHAPTER II Article 7 (new) Notification to the Biosafety Clearing House The Commission shall notify to the Biosafety Clearing House, on behalf of the Community, any final decision regarding Community use, including placing on the market, of a GMO that may be subject to transboundary movements for release into the environment. PE / /15 AM\ doc

9 The same requiqrement of notification to the Biosafety Clearing House for transboudnary movements of GMOs for direct use as food or feed or for processing laid down in Article 8 should apply to GMOs for release into the environment. Article 8 of the Cartagena Protocol lays down similar requirements. Moreover, Article 20 of the Cartagena Protocol concerning 'Information Sharing and the Biosafety Clearing House' also refers to living modified organisms and not only GMOs for direct use as food or feed or for processing. Or. da Amendment 55 CHAPTER II, Section 2 b (new), Transit Article 8 (b) (new) Article 8 b Notification of transit Where a Party of transit requires under its domestic regulatory framework the notification of the transport of genetically modified organisms or products thereof, the exporter shall comply with the law and rules of the Party of transit. The amendment extends the obligation to comply with domestic laws of the Party of import (see the rapporteur's amendment 29) to the transit of GMOs. AM\ doc 9/15 PE /45-62

10 Amendment by Torben Lund Amendment 56 CHAPTER II Article 9 (new) A Party may take a decision on the import of living modified organisms intended for direct use as food or feed, or for processing, under its domestic regulatory framework that is consistent with the objective of the Cartagena Protocol. It is important that the Regulation does not give the importing countries fewer powers than the Cartagena Protocol. This amendment is taken directly from Article 11, paragraph 4 of the Cartagena Protocol. Or. da Amendment 57 CHAPTER III Article 10 (1) 1. As soon as a Member State becomes aware of an occurrence, under its jurisdiction, resulting in a release of GMOs that leads, or may lead, to an unintentional transboundary movement that is likely to have significant adverse effects on the conservation and sustainable use of biological diversity, taking into account risks to human health, that Member State shall take the following action: 1 As soon as a Member State becomes aware of an occurrence, under its jurisdiction, resulting in a release of GMOs that leads, or may lead, (a) (b) to an unintentional transboundary movement that may have significant adverse effects on the conservation and sustainable use of biological diversity, taking into account risks to human health, or to a deliberate release, not approved by other Member States, affected or PE / /15 AM\ doc

11 potentially affected other states, That Member State shall take the following action: Member States should also notify occurences which may lead to unauthorised releases of GMOs in other states. Amendment 58 CHAPTER III Article 10 (1) (a) (new) (1a) Member States shall take appropriate measures to prevent unintentional transboundary movements of living modified organisms. Article 10 implements Article 17 of the Biosafety Protocol dealing with unintentional transboundary movements. However, the Commission's proposal fails to implement another provision of the Biosafety Protocol which is crucial when it comes to unintentional transboundary movements of GMOs. Article 16 (3) of the Biosafety Protocol reads: "Each Party shall take appropriate measures to prevent unintentional transboundary movements of living modified organisms, including such measures as requiring a risk assessment to be carried out prior to the first release of a living modified organism." AM\ doc 11/15 PE /45-62

12 While the risk assessment prior to the first release of GMOs is already mandatory under Directive 2001/18/EC, the Protocol's obligation to prevent unintentional transboundary movements is clearly not limited to the measure of risk assessment ("including"). Amendment 59 CHAPTER IV Article 11 (2) (e) (e) any summary of risk assessments or environmental review of GMOs generated by the Community regulatory process and carried out in accordance with procedures similar to those laid down in Annex II to Directive 2001/18, including, where appropriate, relevant information regarding products thereof, namely, processed materials that are of GMO origin, containing detectable novel combinations of replicable genetic material obtained through the use of modern biotechnology, in accordance with Article 20.3(c) of the Protocol; (e) any summary of risk assessments or environmental reviews of GMOs and products thereof generated by the Community regulatory process and carried out in accordance with the procedures laid down therein; The amendment clarifies and shortens the provision and adapts it to the Commission's proposal on GM food and feed (COM(2001) 425). PE / /15 AM\ doc

13 Amendment by Torben Lund Amendment 60 CHAPTER IV Article 13 The Member States shall lay down the rules on penalties applicable to infringements of the provisions of this Regulation and shall take all measure necessary to ensure that they are implemented.. The penalties provided for must be effective, proportionate and dissuasive. The Member States shall notify those provisions to the Commission, by (date) at the latest [180 days following the date of publication of this Regulation in the Official Journal of the European Communities] and shall notify it without delay of any subsequent amendment affecting them. The Member States shall, after joint consultation, lay down the rules on uniform penalties applicable to infringements of the provisions of this Regulation and shall take all measure necessary to ensure that they are implemented.. The penalties provided for must be effective, proportionate and dissuasive. The Member States shall notify those provisions to the Commission, by (date) at the latest [180 days following the date of publication of this Regulation in the Official Journal of the European Communities] and shall notify it without delay of any subsequent amendment affecting them. It is important that no Member State of the EU becomes attractive to multinational companies for the exportation of GMOs because it has lenient penalties for infringement of the Regulation and does not have the capability to implement the measures required. The penalties should be uniform. Or. da Amendment by Jonas Sjöstedt AM\ doc 13/15 PE /45-62

14 Amendment 61 CHAPTER IV Article 14 (a) (new) "Capacity of Parties and non-parties of import to fulfil their responsibilities" (a) The Commission and Member States shall co-operate in the development and/or strengthening of human resources and institutional capacities in biosafety, including biotechnology to the extent that it is required for biosafety, for the purpose of the effective implementation of this Protocol, in Parties which are developing countries or economies in transition, including those which have applied for membership of the European Community. To this end, it shall make the resources and expertise at its disposal available to countries seeking advice and assistance in the development of effective means to implement the Protocol s requirements. (b) If, due to temporary crises, such as civil wars, the Commission has good reason to believe that the relevant authority of the Party of import cannot guarantee the safe handling and use, as defined in the Protocol and any subsequent agreements based upon it, of any GMOs or products thereof the export of which would under normal circumstances be permitted under this Regulation, it may forbid such export until such time as it can be shown that the critical situation no longer prevails. In doing so, it must give a clear and reasoned explanation both to the exporter and to the public. PE / /15 AM\ doc

15 Part (a) of this new Article incorporates Article 22 of the Protocol, inexplicably ignored in the Commission's proposal. The Protocol will function as intended only if all Parties have the capacity to implement its requirements and co-operate with other Parties in building upon its achievements. Many Parties do not have this capacity, yet the fact that they have signed and, in some cases, ratified, and in others announced their intention to ratify, the Protocol demonstrates that this is a result of a lack of resources rather than a failure of will. The European Union is uniquely placed to assist in the development of this capacity. In the case of applicant countries, moreover, it has a pressing need to do so. Part (b) provides for emergency situations, such as civil war. Amendment 62 Annex I (i) (i) Intended use of the genetically modified organism or products thereof, namely, processed materials that are of genetically modified organism origin, containing detectable novel combinations of replicable genetic material obtained through techniques listed in Annex I A, Part 1 of Directive 2001/18/EC. (i) Intended use of the living modified organism or products thereof, namely, processed materials that are of genetically modified organism origin. The limitation to processed materials "containing detectable novel combinations of replicable genetic material" obviously contradicts the new approach the Commission has taken domestically with regard to the traceability of GMOs, GM food and GM feed (see COM(2001) 182). Given the fact that Parliament is in support of this approach, the Annex I (i) should be adapted accordingly. AM\ doc 15/15 PE /45-62