A4-0070/97

Proposal for a Council Directive amending Directive 90/219/EEC on the contained use of genetically modified micro-organisms (COM(95)0640 - C4-0271/96 - 95/0340(SYN))

The proposal was approved with the following amendments:

(Amendment 1)

Preamble

>Original text>

THE COUNCIL OF THE EUROPEAN UNION,

>Text following EP vote>

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,

>Original text>

Having regard to the Treaty establishing the European Community, and in particular Article 130s thereof,

>Text following EP vote>

Having regard to the Treaty establishing the European Community, and in particular Article 100a thereof,

>Original text>

Having regard to the proposal from the Commission,

>Text following EP vote>

Having regard to the proposal from the Commission,

>Original text>

Acting in accordance with the procedure laid down in Article 189c of the Treaty, in cooperation with the European Parliament,

>Text following EP vote>

Acting in accordance with the procedure laid down in Article 189b of the Treaty,

>Original text>

Having regard to the opinion of the Economic and Social Committee,

>Text following EP vote>

Having regard to the opinion of the Economic and Social Committee,

(Amendment 2)

Recital 3a (new)

>Text following EP vote>

Whereas the principle of good microbiological practice and the principles of safety and health at work laid down in the relevant Community laws should apply to all activities in which genetically modified micro-organisms are used;

(Amendment 3)

Recital 4a (new)

>Text following EP vote>

Whereas specific measures should be adopted and used for the control of the disposal of material from the activities of the contained use of genetically modified micro- organisms;

(Amendment 4)

ARTICLE 1(1)(a)

Article 2(a)(Directive 90/219/EEC)

>Original text>

(a) The following words are added at the end of paragraph (a): 'including viruses, viroids and animal and plant cells in culture, but excluding naked nucleic acid molecules¨;

>Text following EP vote>

Deleted

(Amendment 68)

ARTICLE 1(1)(c)

Article 2(c) (Directive 90/219/EEC)

>Original text>

(c) "contained use¨ shall mean: any operation in which micro- organisms are genetically modified or in which such genetically modified micro- organisms are cultured, stored, used, transported or destroyed (deleted words), and for which physical barriers, or a combination of physical barriers together with chemical and or/biological barriers, are used to limit their contact with the general population and the environment ; or any activity in which genetically modified micro-organisms are disposed of, for which physical or chemical or biological barriers, or any combination of these types, are used to limit their contact with the general population and the environment;

>Text following EP vote>

(c) "contained use¨ shall mean: any operation in which micro- organisms are genetically modified or in which such genetically modified micro- organisms are cultured, stored, used, transported or destroyed (deleted words), and for which physical barriers, or a combination of physical barriers together with chemical and or/biological barriers, are used to avoid their contact with the general population and the environment ; or any activity in which genetically modified micro-organisms are disposed of, for which physical or chemical or biological barriers, or any combination of these types, are used to avoid their contact with the general population and the environment;

(Amendment 6)

ARTICLE 1(1)(da)(new)

Article 2(h) (Directive 90/219/EEC)

>Text following EP vote>

(da) Paragraph (h) is replaced by the following:

"(h) 'notification' shall mean the presentation of the requisite documents and information to the competent authorities of a Member State.¨

(Amendment 7)

ARTICLE 1(2)

Article 3 (Directive 90/219/EEC)

>Original text>

This Directive shall not apply where genetic modification is obtained through the use of the techniques or methods listed in Annex II, or for contained-use activities involving other types of genetically modified micro- organisms known to be safe for human health and the environment. Such types of genetically modified micro-organisms and their characteristics are listed in Annex II, Part B;

>Text following EP vote>

This Directive shall not apply where genetic modification is obtained through the use of the techniques or methods listed in Annex II, or for contained-use activities involving other types of genetically modified micro- organisms known to be safe for human health and the environment. Such types of genetically modified micro-organisms and their characteristics are listed in Annex II, Parts B and Ba;

(Amendment 8)

ARTICLE 1(5)(a)

Article 6(3), introduction (Directive 90/219/EEC)

>Original text>

3. The assessment should result in the categorization of the contained-use activities in the following four classes of risk:

>Text following EP vote>

3. The assessment, in accordance with the procedure set out in Annex III, must result in the final categorization of the contained-use activities in the following four classes and serve to determine the level of containment in accordance with Article 6a:

(Amendment 9)

ARTICLE 1(5)(aa) (new)

Article 6(3a )(new) (Directive 90/219/EEC)

>Text following EP vote>

(aa) The following paragraph 3a is added:

"3a. Where there is doubt as to which of two classes of risk is appropriate for the proposed contained-use activity(ies), the higher classification should be assigned until sufficient evidence justifies the use of the lower classification.¨

(Amendment 10)

ARTICLE 1(5)(ba) (new)

Article 6(4a) (new) (Directive 90/219/EEC)

>Text following EP vote>

(ba) The following paragraph 4a is added:

"4a. When assessing the risk entailed in an activity involving genetically modified micro- organisms, the question of disposal shall be taken especially into account. Where appropriate, the necessary safety measures shall be implemented in order to protect human health and the environment."

(Amendment 11)

ARTICLE 1(6)

Article 6a(1) (Directive 90/219/EEC)

>Original text>

1. The user shall apply the containment and control measures from the appropriate Table(s) in Annex IV corresponding to the risk class of the activity, so as to keep workplace and environmental exposure to any genetically modified micro-organisms to the lowest reasonably practicable level, and so that a high level of safety is ensured.

>Text following EP vote>

1. The user shall apply the containment and control measures from the appropriate Table(s) in Annex IV corresponding to the class of the activity or activities, so as to keep workplace and environmental exposure to any genetically modified micro- organisms to the lowest reasonably practicable level, and so that a high level of safety is ensured.

(Amendment 12)

ARTICLE 1(6)

Article 6a(2)(b) (Directive 90/219/EEC)

>Original text>

(b) there is reason to suspect that the assessment is no longer adequate as judged in the light of new scientific or technical knowledge.

>Text following EP vote>

(b) there is reason to suspect or the competent authority is made aware under the formal procedure for this purpose to be laid down by the Commission that the assessment is no longer adequate as judged in the light of new scientific or technical knowledge.

(Amendment 13)

ARTICLE 1(6)

Article 6a(2a) (new) (Directive 90/219/EEC)

>Text following EP vote>

2a. All users shall be required to provide as part of all notifications of activities under this Directive, a certificate of liability insurance of sufficient value to compensate all persons likely to be harmed by a failure of containment and control measures.

(Amendment 14)

ARTICLE 1(6)

Article 6a(2b) (new) (Directive 90/219/EEC)

>Text following EP vote>

2b. As a minimum, in addition to specific safety measures, the following OECD 'Principles of good microbiological practice at work' shall invariably apply to genetically modified micro- organisms:

>Text following EP vote>

(a) in suspect cases, tests shall be carried out to ascertain the presence of viable used organisms outside the physical boundaries within which they are primarily contained;

>Text following EP vote>

(b) provision shall be made for basic and regular further training of personnel;

>Text following EP vote>

(c) biological safety committees or subcommittees shall be set up according to requirements;

>Text following EP vote>

(d) internal practical rules of conduct shall be drawn up and enforced to guarantee the safety of personnel.

(Amendment 15)

ARTICLE 1(6)

Article 6a(2c) (new) (Directive 90/219/EEC)

>Text following EP vote>

2c. 'Good microbiological practice' shall be reviewed by the user every year. The persons employed in this area shall take part in the review.

(Amendment 16)

ARTICLE 1(8)

Article 10(1) (Directive 90/219/EEC)

>Original text>

1. For the first and subsequent class 2 activities to be carried out in premises notified in accordance with Article 8, a notification containing the information listed in Annex V, Part B shall be submitted.

>Text following EP vote>

1. For the first and subsequent class 2 contained use to be carried out in premises notified in accordance with Article 8, a notification containing the information listed in Annex V, Part B shall be submitted.

(Amendment 17)

ARTICLE 1(8)

Article 10(2a) (new) (Directive 90/219/EEC)

>Text following EP vote>

2a. The applicant can, however, himself request a decision on a formal authorization from the competent authority. This decision must be made within a maximum of 45 days from the notification.

(Amendment 18)

ARTICLE 1(9)

Article 10a(1) (Directive 90/219/EEC)

>Original text>

1. For first and subsequent Class 3 or Class 4 activities to be carried out in premises notified in accordance with Article 8, a notification containing the information listed in Annex V, Part C shall be submitted.

>Text following EP vote>

1. For first and subsequent Class 3 activities to be carried out in premises notified in accordance with Article 8, a notification containing the information listed in Annex V, Part C shall be submitted.

(Amendment 19)

ARTICLE 1(9)

Article 10a(2) (Directive 90/219/EEC)

>Original text>

2. If no previous notification has been submitted for class 3 or a higher class of activities, the contained use may not proceed without the consent of the competent authority. The competent authority shall communicate its decision in writing at the latest 90 days after submission of the notification.

>Text following EP vote>

2. If no previous notification has been submitted for class 3 or a higher class of contained use, the contained use may not proceed without the consent of the competent authority. The competent authority shall communicate its decision in writing at the latest 90 days after submission of the notification.

(Amendment 20)

ARTICLE 1(9)

Article 10a(3) (Directive 90/219/EEC)

>Original text>

3. If a previous notification has been submitted for Class 3 or a higher class of activities and the associated consent requirements have been satisfied, the contained use may in absence of any indication to the contrary from the competent authority proceed 45 days after submission of the new notification, or earlier with the agreement of the competent authority.

>Text following EP vote>

3. If a previous notification has been submitted for Class 3 and the associated consent requirements have been satisfied, the contained use may in absence of any indication to the contrary from the competent authority proceed 45 days after submission of the new notification, or earlier with the agreement of the competent authority.

(Amendment 21)

ARTICLE 1(9)

Article 10a(3a) (new) (Directive 90/219/EEC)

>Text following EP vote>

3a. If a previous notification has been submitted for Class 4 activities and the associated consent requirements have been satisfied, the contained use may not proceed without the consent of the competent authority. The competent authority shall communicate its decision in writing at the latest 45 days after submission of the notification.

(Amendment 22)

ARTICLE 1(9a) (new)

Article 10b (new) (Directive 90/219/EEC)

>Text following EP vote>

9a. The following Article 10b is inserted:

'Article 10b

For first and subsequent Class 4 activities to be carried out in premises notified in accordance with Article 8, a notification containing the information listed in Annex V, Part C shall be submitted.

>Text following EP vote>

The contained use may not proceed without the consent of the competent authority. If no previous notification has been submitted for Class 4 activities, the competent authority shall communicate its decision in writing at the latest 90 days after submission of the notification. If a previous notification has been submitted for Class 4 activities, the competent authority shall communicate its decision in writing at the latest 45 days after submission of the notification.¨

(Amendment 23)

ARTICLE 1(10)(a)

Article 11(1) (Directive 90/219/EEC)

>Original text>

(a) The words 'Article 8, Article 9(2) and Article 10" in paragraph 1 are replaced by the words 'Articles 8, 10 and 10a¨;

>Text following EP vote>

(a) The words 'Article 8, Article 9(2) and Article 10" in paragraph 1 are replaced by the words 'Articles 8, 10, 10a and 10b';

(Amendment 24)

ARTICLE 1(10)(e)

Article 11(6) (Directive 90/219/EEC)

>Original text>

(e) In paragraph 6, the words 'paragraphs 4 and 5" are replaced by the words 'Articles 10 and 10a¨.

>Text following EP vote>

(e) In paragraph 6, the words 'paragraphs 4 and 5" are replaced by the words 'Articles 10, 10a and 10b"

(Amendment 25)

ARTICLE 1(11)

Article 12(1) (Directive 90/219/EEC)

>Original text>

1. If the user becomes aware of relevant new information or modifies the contained use in a way which could have significant consequences for the risks posed by it, the competent authority shall be informed as soon as possible and the notification under Articles 8, 10 and 10a modified.

>Text following EP vote>

1. If the user becomes aware of relevant new information or modifies the contained use in a way which could have significant consequences for the risks posed by it, the competent authority shall be informed as soon as possible and the notification under Articles 8, 10, 10a and 10b modified.

(Amendment 26)

ARTICLE 1(12)

Article 13 (Directive 90/219/EEC)

>Original text>

Where a Member State considers it appropriate, it may provide that groups or the public shall be consulted on aspects of the proposed contained use, in accordance with Article 19.

>Text following EP vote>

Where a Member State considers it appropriate, it may provide that, for Class 2, 3 or 4 activities, groups or the public shall be consulted on aspects of the proposed contained use related to health and environmental protection and emergency plans, in accordance with Article 19.

(Amendment 27)

ARTICLE 1(13)

Article 14(b) (Directive 90/219/EEC)

>Original text>

(b) Information on emergency plans is supplied in an appropriate manner, and without their having to request it, to bodies and authorities liable to be affected by the accident. The information shall be updated at appropriate intervals. It shall also be made publicly available.

>Text following EP vote>

(b) Information on emergency plans and safety measures is supplied in an appropriate manner, and without their having to request it, to authorities, including regional administrative authorities, likely to be affected by the accident and a system for cooperation with the above authorities established to guarantee that the public can be informed in detail. The information shall be updated at appropriate intervals.

(Amendment 28)

ARTICLE 1(13a) (new)

Article 14a (new) (Directive 90/219/EEC)

>Text following EP vote>

13a. The following Article 14a is inserted:

>Text following EP vote>

'Article 14a

>Text following EP vote>

Legally responsible users of genetically modified micro- organisms shall have full civil and criminal liability for any damage to human health and the environment caused by the uses in question. Before the activities begin, they shall take out sufficient liability insurance to cover such losses as might be occasioned thereby.¨

(Amendment 30)

ARTICLE 1(14)

Article 15(Directive 90/219/EEC)

>Original text>

14. Paragraph 1 of Article 15 is amended as follows :

>Text following EP vote>

14. Article 15 is amended as follows:

>Text following EP vote>

(-a) The introductory part of paragraph 1 is replaced by the following:

>Text following EP vote>

"1. Member States shall take the necessary measures to ensure that, in the event of an accident of such a nature as to involve serious damage to public health or the environment, the user shall be required immediately to inform the competent authority specified in Article 11 and provide the following information:"

>Original text>

(a) In the second indent, the word 'released¨ is replaced by the word 'concerned¨;

>Text following EP vote>

(a) In the second indent of paragraph 1, the word 'released¨ is replaced by the words 'concerned and unintentionally released';

>Original text>

(b) In the fourth indent, the word 'emergency¨ is deleted.

>Text following EP vote>

(b) In the fourth indent of paragraph 1, the word 'emergency¨ is deleted;

>Text following EP vote>

(ba) In the second indent of paragraph 2, the word 'avoid¨ is replaced by the word 'prevent¨.

(Amendment 31)

ARTICLE 1(14a) (new)

Article 16(1)(a) (new)(Directive 90/219/EEC)

>Text following EP vote>

14a. In point (a) of paragraph 1 of Article 16, the word 'liable¨ is replaced by the word 'likely¨;

(Amendment 32)

ARTICLE 1(15)

Article 16(1)(b) (Directive 90/219/EEC)

>Original text>

15. In point (b) of paragraph 1 of Article 16, the phrase 'the identity and quantities of the genetically modified micro- organisms released, the emergency response measures employed and their effectiveness' is replaced by 'the identity and quantities of the genetically modified micro- organisms concerned, the response measures employed and their effectiveness'.

>Text following EP vote>

15. Article 16(1)(b) is replaced by the following:

(b) inform the Commission as soon as possible of any accident of such a nature as to involve serious damage to public health or the environment within the scope of this Directive, giving details of the circumstances of the accident, the identity of the genetically modified micro- organisms released and the quantities concerned, the response measures employed and their effectiveness, and an analysis of the accident including recommendations to limit its effects and avoid similar accidents in the future.

(Amendment 33)

ARTICLE 1(15a) (new)

Article 16(2) (Directive 90/219/EEC)

>Text following EP vote>

15a. In Article 16, paragraph 2 is replaced by the following:

"2. The Commission, in consultation with the Member States, shall establish a procedure for the exchange of information under paragraph 1. It shall also set up and keep at the disposal of the Member States a register of accidents involving possible serious damage to public health or the environment within the scope of this Directive, including an analysis of the causes of the accidents, experience gained and measures taken to avoid similar accidents in the future.¨

(Amendment 34)

ARTICLE 1(15b) (new)

Article 17 (Directive 90/219/EEC)

>Text following EP vote>

15b. Article 17 is replaced by the following:

>Text following EP vote>

'Article 17

>Text following EP vote>

Member States shall ensure that the competent authority organizes inspections and other control measures to ensure user compliance with this Directive. Users shall be required to keep appropriate records.¨

(Amendment 35)

ARTICLE 1(16)

Article 18(1) (Directive 90/219/EEC)

>Original text>

1. Member States shall send to the Commission, at the end of each year, a summary report on the Class 3 and Class 4 contained uses notified under Article 10a, including the description, purpose and risks of the activity or activities.

>Text following EP vote>

1. Member States shall send to the Commission, at the end of each year, a summary report on the Class 3 and Class 4 contained uses notified under Articles 10a and 10b, including the description, purpose and risks of the activity or activities.

(Amendment 36)

ARTICLE 1(17)

Article 19(4), first indent (Directive 90/219/EEC)

>Original text>

- the characteristics of the genetically modified micro- organisms, name and address of the notifier, and location of use;

>Text following EP vote>

- the characteristics with respect to safety of the genetically modified micro-organisms, name and address of the notifier, and location of use;

(Amendment 37)

ARTICLE 1(18)

Article 20 (Directive 90/219/EEC)

>Original text>

18. In Article 20, the words 'Annexes II to V¨ are replaced by the words 'Annexes I to V¨.

>Text following EP vote>

18. In Article 20, the words 'Annexes II to V¨ are replaced by the words 'Annex III, paragraphs 1, 2, 3, 4 and 5 and Annexes IV and V¨.

(Amendment 38)

ARTICLE 1(18a) (new)

Article 20a (new) (Directive 90/219/EEC)

>Text following EP vote>

18a. The following Article 20a is inserted:

>Text following EP vote>

'Article 20a

>Text following EP vote>

Within six months of the implementation date of this Directive specified in Article 2, the criteria for the inclusion of certain types of genetically modified micro-organisms in Annex II, Part B, shall be laid down on a proposal from the Commission in accordance with Article 100a of the EC Treaty.¨

(Amendment 39)

ARTICLE 1(18b) (new)

Article 21 (Directive 90/219/EEC)

>Text following EP vote>

18b. Article 21 is replaced by the following:

>Original text>

>Text following EP vote>

'Article 21

>Original text>

>Text following EP vote>

1. The Commission shall be assisted by a committee composed of the representatives of the Member States and chaired by the representative of the Commission.

>Original text>

>Text following EP vote>

2. The representative of the Commission shall submit to the committee a draft of the measures to be taken. The committee shall deliver its opinion on the draft within a time limit which the chairman may lay down according to the urgency of the matter. The opinion shall be delivered by the majority laid down in Article 148(2) of the Treaty in the case of decisions which the Council is required to adopt on a proposal from the Commission. The votes of the representatives of the Member States within the committee shall be weighted in the manner set out in that Article. The chairman shall not vote.

>Original text>

>Text following EP vote>

3. The Commission shall adopt measures which shall apply immediately. However, if these measures are not in accordance with the opinion of the committee, they shall be communicated by the Commission to the Council forthwith. In that event the Commission may defer application of the measures which it has decided for a period of not more than three months from the date of such communication.

The Council, acting by a qualified majority, may take a different decision within the time-limit referred to in the previous subparagraph.

>Original text>

>Text following EP vote>

4. The reasons for the decision and the minutes of this committee shall be made available to the public.

>Text following EP vote>

5. The Commission shall submit to the European Parliament every three years and for the first time ...... a summary report on the implementation of the Directive, and in particular the measures it has adopted and the implemented and planned changes to the technical annexes.¨

(Amendment 40)

ANNEX (1)(b)(ii)

Annex I, Part 2 (2) (Directive 90/219/EEC)

>Original text>

(2) natural processes such as: conjugation, transduction, transformation;

>Text following EP vote>

(2) natural processes such as: conjugation, transduction, transformation or any other natural process;

(Amendment 41)

ANNEX (3)

Annex II, Part B (Directive 90/219/EEC)

>Original text>

B. Types of genetically modified micro-organisms which have been shown to be safe for human health and the environment and which are, therefore, excluded from the Directive:

>Text following EP vote>

B. Criteria to determine the safety of genetically modified micro- organisms (GMMs) for human health and the environment:

(Amendment 42)

ANNEX (3)

Annex II, Part Ba (new) (Directive 90/219/EEC)

>Text following EP vote>

Ba. Types of genetically modified micro-organisms (GMMs) meeting the criteria set out in Part B:

(Amendment 43)

ANNEX (4)

Annex III (Directive 90/219/EEC)

>Original text>

PRINCIPLES TO BE FOLLOWED FOR THE ASSESSMENT REFERRED TO IN ARTICLE 6

>Text following EP vote>

PRINCIPLES TO BE FOLLOWED FOR THE ASSESSMENT REFERRED TO IN ARTICLE 6

>Original text>

Elements of assessment

1. The following should be considered as potentially harmful effects :

- disease to humans, animals or plants;

- adverse effects resulting from the inability to treat disease or offer effective prophylaxis;

- adverse effects resulting from establishment or dissemination in the environment;

- adverse effects resulting from transfer of genes to other organisms.

>Text following EP vote>

Elements of assessment

1. The following should be considered as potentially harmful effects :

- disease to humans, animals or plants;

- adverse effects resulting from the inability to treat disease or offer effective prophylaxis;

- adverse effects resulting from establishment or dissemination in the environment;

- adverse effects resulting from transfer of genes to other organisms.

>Original text>

2. The assessment referred to in Article 6 should be based on the following:

a. The identification of any potentially harmful effects of the operation in particular any potentially harmful effects associated with:

(i) the recipient micro- organism;

(ii) the inserted (donated) genetic material;

(iii) the vector;

(iv) the donor micro-organism (if the donor micro- organism is used during the operation);

(v) the resulting genetically modified micro-organisms.

b. The severity of the potentially harmful effects.

c. The likelihood of the potentially harmful effects being realized.

>Text following EP vote>

2. The assessment referred to in Article 6 should be based on the following:

a. The identification of any potentially harmful effects of the operation in particular any potentially harmful effects caused by:

(i) the recipient micro- organism;

(ii) the inserted (donated) genetic material;

(iii) the vector;

(iv) the donor micro-organism (if the donor micro- organism is used during the operation);

(v) the resulting genetically modified micro-organisms.

b. The severity of the potentially harmful effects.

c. The likelihood of the potentially harmful effects being realized.

>Original text>

Procedure

3. In order to arrive at the categorization of a particular activity, as referred to in Article 6, the user may take into consideration the risk class of the recipient, the vector and, if applicable, donor micro-organism as given in other Community legislation, international or national schemes (e.g. WHO, NIH etc.).

>Text following EP vote>

Procedure

3. In order to arrive at the categorization of a particular activity, as referred to in Article 6, the user shall take into consideration the risk class of the recipient, the vector and, if applicable, donor micro-organism, as given in other Community legislation, in particular Directives 90/679/EEC and 93/88/EEC, and international or national schemes (e.g. WHO, NIH etc.).

>Original text>

These classification schemes concern natural micro-organisms and are usually based on the ability of micro-organisms to cause disease to humans or animals, and on the severity and transmissibility of the disease likely to be caused. The user may also take into consideration classification schemes referring to plant pathogens (which are usually established on a national basis). The abovementioned classification schemes give only a provisional indication of the risk class of the activity and the corresponding set of containment and control measures required.

>Text following EP vote>

These classification schemes concern natural micro-organisms and are usually based on the ability of micro-organisms to cause disease to humans or animals, and on the severity and transmissibility of the disease likely to be caused. The user may also take into consideration classification schemes referring to plant pathogens (which are usually established on a national basis). The abovementioned classification schemes give only a provisional indication of the risk class of the activity and the corresponding set of containment and control measures required.

>Original text>

4. The final classification and selection of control measures must be made in the light of:

(i) any harmful properties (see above) which the vector or inserted material might confer on the recipient, or any alteration of the recipient's existing properties;

(ii) the characteristics of the operation (e.g. its nature, scale);

(iii) the characteristics of the environment likely to be exposed to the genetically modified micro- organisms (e.g. whether in the environment likely to be exposed to the genetically modified micro-organisms there are known biota which can be adversely affected by the micro-organisms used in the contained-use activity).

>Text following EP vote>

4. The final classification and selection of control measures must be made in the light of:

(i) any harmful properties (see above) which the vector or inserted material might confer on the recipient, or any alteration of the recipient's existing properties;

(ii) the characteristics of the operation (e.g. its nature, scale);

(iii) the characteristics of the environment likely to be exposed to the genetically modified micro-organisms (e.g. whether in the environment likely to be exposed to the genetically modified micro-organisms there are known biota which can be adversely affected by the micro- organisms used in the contained-use activity).

>Original text>

5. The analysis carried out as described under paragraph 4 above may lead to a categorization of the risk of the activity higher or lower than the provisional one. The check foreseen in paragraph 4 should be repeated, until final classification is stable.

>Text following EP vote>

5. The analysis carried out as described under paragraph 4 above may lead to a categorization of the risk of the activity higher or lower than the provisional one. The check foreseen in paragraph 4 should be repeated, until final classification is stable.

>Text following EP vote>

Risk assessment for human health

5a. The first stage in the risk assessment for human health should be to identify the risk class of the recipient micro-organism involved in the operation. Recipient micro- organisms are classified into four classes of risk on the basis of potential effects on a healthy human adult (Table 1). These classes of risk correspond exactly to the categorization of the contained use activities in the four Classes of risk referred to in Article 6(3). The identification (or categorization) of the class of risk for human health gives only a provisional indication of the class of risk of the activity and the corresponding set of containment and control measures required.

>Text following EP vote>

Table 1: 'The four classes of risk for human health¨

Recipient micro-organism Class of risk

Not associated with disease 1

- ----------------------------------- -

Associated with human 2

disease which is rarely

serious and for which

preventive or therapeutic

interventions are often

available

------------------------------------ ------------------

Associated with serious or 3

lethal human disease for

which preventive or therapeutic

interventions may

be available (high individual

risk but low community

risk)

------------------------------------ ------------------

Associated with serious or 4

lethal human disease for

which preventive or therapeutic

interventions are

not usually available (high

individual risk

and high community risk)

>Text following EP vote>

5a. 1. The following aspects should be considered for the allocation of the recipient micro-organism to classes of risk 1 to 4 for human health:

- nature of pathogenicity and virulence, infectivity, toxicity and vectors of disease transmission;

- nature of indigenous vectors, where they could mobilize the inserted DNA, and the frequency of mobilization;

- nature and stability of disabling mutations;

- host range (if relevant);

- any significant physiological traits which may be altered in the final GMM and if relevant their stability;

- interaction with, and effects on, other organisms in the environment (including likely competitive, pathogenic or symbiotic properties);

- ability to form survival structures (such as spores or sclerotia).

>Text following EP vote>

5a. 2. In order to arrive at the categorization of the class of risk for human health the user should also take into account the classification schemes of the recipient micro-organisms as given in other Community legislation or international schemes (e.g. the catalogues of bacteria, fungi, parasites, viruses and other biological agents with their risk classification in Council Directives 90/679/EEC and 93/88/EEC, and classification schemes of the WHO and NIH etc.) and their updated versions due to new scientific knowledge and technical progress.

>Text following EP vote>

Final risk assessment

5b. The risk assessment for human health and the risk assessment for the environment should be considered together in order to arrive at and allocate the final risk assessment of categorization of the activities involved in the production of the given genetically modified micro- organism in the given facilities. This final assessment will be at least the higher of the two classes of risk assigned for the protection of human health and the environment.

(Amendment 44)

ANNEX (5)

Annex IV, Preface, paragraph 4 (Directive 90/219/EEC)

>Original text>

Table Ia presents minimum requirements for laboratory activities.

>Text following EP vote>

Table Ia presents minimum requirements for activities carried out in research laboratories.

(Amendment 45)

ANNEX (5)

Annex IV, Preface, paragraph 7 (Directive 90/219/EEC)

>Original text>

Table II presents minimum requirements for activities other than laboratories activities.

>Text following EP vote>

Table II presents minimum requirements for activities other than research laboratory activities.

(Amendment 46)

ANNEX (5)

Annex IV, Table Ia, title (Directive 90/219/EEC)

>Original text>

Containment and control measures for laboratory activities

>Text following EP vote>

Containment and control measures for activities carried out in research laboratories

(Amendment 47)

ANNEX (5)

Annex IV, Table Ia, line 3 (Directive 90/219/EEC)

>Original text>

3 Surfaces resistant to acids, alkalis, solvents, disinfectants

>Text following EP vote>

3 Surfaces resistant to water and decontamination agents and which are easy to clean

>Original text>

Containment levels:

1 yes (bench)

2 yes (bench)

3 yes (bench, floor)

4 yes (bench, floor, ceiling, walls)

>Text following EP vote>

Containment levels:

1 yes (floor)

2 yes (floor)

3 yes (floor, walls, ceiling)

4 yes (floor, walls, ceiling and surfaces resistant to chemicals)

(Amendment 48)

ANNEX (5)

Annex IV, Table Ia, line 3a(new) (Directive 90/219/EEC)

>Text following EP vote>

3a Bench tops impervious to water and resistant to acids, alkalis, solvents and disinfectants

>Text following EP vote>

Containment levels:

1 yes

2 yes

3 yes

4 yes

(Amendment 49)

ANNEX (5)

Annex IV, Table Ia, line 12, heading (Directive 90/219/EEC)

>Original text>

12 Washing and decontamination provisions for personnel

>Text following EP vote>

12 Handwashing and decontamination provisions for personnel

(Amendment 50)

ANNEX (5)

Annex IV, Table Ia, line 18, column 1 (Directive 90/219/EEC)

>Original text>

1 optional

>Text following EP vote>

1 yes

(Amendment 51)

ANNEX (5)

Annex IV, Table Ic, line 3, column 2 (Directive 90/219/EEC)

>Original text>

2 optional

>Text following EP vote>

2 yes

(Amendment 52)

ANNEX (5)

Annex IV, Table Ic, line 4, column 2 (Directive 90/219/EEC)

>Original text>

2 yes (floor)

>Text following EP vote>

2 yes (floor and walls)

(Amendment 53)

ANNEX (5)

Annex IV, Table II, line 2, column 1 (Directive 90/219/EEC)

>Original text>

1 no

>Text following EP vote>

1 yes, minimize release

(Amendment 54)

ANNEX (5)

Annex IV, Table II, line 9 (Directive 90/219/EEC)

>Original text>

9 Surfaces resistant to acids, alkalis, solvents, disinfectants

>Text following EP vote>

9 Surfaces resistant to water and decontamination agents and which are easy to clean

>Original text>

Containment levels

1 optional

2 optional

3 yes (bench if any, floor)

4 yes (bench, floor, ceiling, walls)

>Text following EP vote>

Containment levels

1 optional (floor)

2 yes (floor)

3 yes (floor, walls, ceiling)

4 yes (floor, walls, ceiling and surfaces resistant to chemicals)

(Amendment 55)

ANNEX (5)

Annex IV, Table II, line 9a (new) (Directive 90/219/EEC)

>Text following EP vote>

9a Bench tops impervious to water and resistant to acids, alkalis, solvents and disinfectants

>Text following EP vote>

Containment levels

1 yes

2 yes

3 yes

4 yes

(Amendment 56)

ANNEX (5)

Annex IV, Table II, line 16, heading (Directive 90/219/EEC)

>Original text>

16 Washing and decontamination provisions for personnel

>Text following EP vote>

16 Handwashing and decontamination provisions for personnel

(Amendment 57)

ANNEX (6)

Annex V, Part B, fifth indent (Directive 90/219/EEC)

>Original text>

- the purpose of the contained use including the expected results;

>Text following EP vote>

- insofar as it affects safety, the purpose of the contained use including the expected results;

(Amendment 58)

ANNEX (6)

Annex V, Part C(c), second indent (Directive 90/219/EEC)

>Original text>

- the purpose of the contained use including the expected results;

>Text following EP vote>

- insofar as it affects safety, the purpose of the contained use including the expected results;

Legislative resolution embodying Parliament's opinion on the proposal for a Council Directive amending Directive 90/219/EEC on the contained use of genetically modified micro-organisms (COM(95)0640 - C4-0271/96 - 95/0340(SYN))

(Codecision procedure: first reading)

The European Parliament,

- having regard to the Commission proposal to the Council, COM(95)0640 - 95/0340(SYN),

- having been consulted by the Council pursuant to Articles 189c and 130s of the EC Treaty (C4-0271/96),

- whereas the legal basis proposed by the Commission is inappropriate and reference should be made instead to Article 100a of the Treaty,

- having regard to Rule 58 of its Rules of Procedure,

- having regard to the report of the Committee on the Environment, Public Health and Consumer Protection and the opinions of the Committee on Research, Technological Development and Energy and the Committee on Legal Affairs and Citizens' Rights (A4-0070/97),

1. Approves the Commission proposal, subject to Parliament's amendments;

2. Calls on the Commission to alter its proposal accordingly, pursuant to Article 189a(2) of the EC Treaty;

3. Calls on the Council to incorporate Parliament's amendments in the common position that it adopts in accordance with Article 189b(2) of the EC Treaty;

4. Points out that the Commission is required to submit to Parliament any modification it may intend to make to its proposal as amended by Parliament;

5. Instructs its President to forward this opinion to the Council and Commission.