Regulation on the preparation of non-operational contingency plans and on information, reporting and teaching obligations (GenTNotfV)

Unofficial table of contents

GenTNotfV

Date of completion: 10.12.1997

Full quote:

" Genetic-emergency decree of 10 December 1997 (BGBl. 2882), as last amended by Article 4 of the Regulation of 28 April 2008 (BGBl I). 766).

Status:

Last amended by Art. 4 V v. 28.4.2008 I 766

For more details, please refer to the menu under Notes

Footnote

(+ + + Text certificate: 17.12.1997 + + +) 
(+ + + Official note from the norm-provider on EC law: 
 Implementation of the 
 EWGRL 219/90 (CELEX Nr: 390L0219) + + +) 

  

This Regulation provides for the implementation of Articles 14 to 16 of Council Directive 90 /219/EEC on the contained use of genetically modified micro-organisms of 23 April 1990 (OJ L 136, 31.5.1990, p. EC No L 117 p. 1). Unofficial table of contents

Input formula

Pursuant to Section 30 (2) (16) of the German Genetic Engineering Act, as amended by the Notice of 16 December 1993 (BGBl. 2066), as defined by Article 5 (1) of the Law of 24 June 1994 (BGBl). I p. 1416), the Federal Government is ordering: Unofficial table of contents

§ 1 Scope

This Regulation shall apply to genetic engineering plants in which genetic engineering works of the safety level 2, 3 or 4 are carried out within the meaning of Section 7 (1) of the Gentechnikgesetz. § § 3 and 4 do not apply to genetic engineering plants, in which genetic engineering works of safety level 2 are carried out. Unofficial table of contents

§ 2 Definitions

(1) An accident within the meaning of this Regulation is any incident involving an unintentional escape of genetically modified organisms by the operator from the genetic engineering plant and at a risk to those in § 1. (2) A non-operational contingency plan within the meaning of this Regulation contains information and lays down organisational and security measures in the event of an accident which is specified in Section 1 (1) of the Genetic engineering law, outside the establishment or The institute's premises on which the genetic engineering plant is operated must be protected. Unofficial table of contents

§ 3 Construction of non-operational contingency plans

The competent authority shall, prior to the start of a genetic engineering work of security level 3 or 4, shall, on the basis of the documents to be supplied by the operator, in cooperation with other authorities in its competence, in particular with: the authorities responsible for the general security and civil protection authorities to draw up an out-of-company emergency plan, provided that there is an accident at a significant risk to the legal goods referred to in § 1 (1) of the Genetic Engineering Act outside the plant or institute premises on which the genetic engineering plant will be able to carry out the operation. The deadlines laid down in § 10 (5) and (6) of the Gentechnikgesetz (Gentechnikgesetz) must also be observed for the preparation of the non-operational emergency plan If the genetic engineering work relevant to the preparation of the non-operational contingency plan is not taken up until a later date, it is sufficient for the non-operational contingency plan to be carried out at the time of the inclusion of these genetic engineering activities. Work is available. When carrying out further genetic engineering work of the same security level, reference may be made to an emergency plan which has already been drawn up, in so far as no safety-related changes to the non-operational contingency plan are concerned. (2) The operator is obliged to provide, at the request of the Authority, all the information necessary for the preparation of the non-operational contingency plan, in so far as these are not included in the notification or approval documents. (3) The non-operational contingency plan shall be provided by the (4) If cross-border effects cannot be ruled out in the event of an accident, the competent authority shall inform the competent authority of the Member States concerned of the European Union or of the other Member States concerned. States Parties to the Agreement on the European Economic Area shall forthwith inform the authorities of the establishment of the non-operational contingency plan and shall communicate their implementation with them. Unofficial table of contents

§ 4 Information on non-operational contingency plans

The competent authority shall have uninvited other authorities whose jurisdiction may also be affected in the event of an accident in accordance with Article 3 (1), first sentence, as well as other entities, where appropriate, on the content of the out-of-company To inform the emergency plan. When carrying out further genetic engineering work of the same level of security, the information shall be provided only if there are safety-related changes to the non-operational contingency plan. The competent authority shall also make available to the public the information on the non-operational contingency plan in a suitable manner. Unofficial table of contents

§ 5 Reporting requirements

In the event of an accident, the operator shall inform the competent authority without delay, indicating the following:

1.

the circumstances of the accident,

2.

the identity and quantities of the escaped genetically modified organisms,

3.

all other information necessary for the assessment of the effects of the accident on the legal goods referred to in Article 1 (1) of the Gentechnikgesetz (German Genetic Law),

4.

the measures taken.

(2) The competent authority shall immediately forward the information referred to in paragraph 1 to the Federal Office for Consumer Protection and Food Safety and to the other authorities whose competence may also be affected. Unofficial table of contents

Section 6 Required measures

The competent authority shall, in cooperation with the operator and with other authorities whose responsibility is concerned, ensure that all the necessary measures are taken in the event of an accident. Unofficial table of contents

§ 7 Analysis of the accident

(1) The competent authority shall draw up an analysis of the accident and, where appropriate, make recommendations to avoid similar accidents in the future and to limit their impact. (2) The competent authority shall forward the analysis to the § 5 (2). Unofficial table of contents

§ 8 Educational obligations

(1) If cross-border effects cannot be ruled out in the event of an accident, the competent authority shall have the responsibility of the other Member States of the European Union and of the other States Parties to the Agreement on the European Economic Area (2) The Federal Office of Consumer Protection and Food Safety shall inform the Commission of the European Communities immediately of any accident. Details of the circumstances of the accident, the identity and quantities of the escaped genetically modified organisms, the emergency measures taken and their effectiveness shall be indicated. An analysis of the accident, together with recommendations to limit its impact and avoid similar accidents, should be transmitted in the future. Unofficial table of contents

§ 9 Transitional Regulation

In the cases referred to in the first sentence of Article 3 (1), the competent authority shall, within three months after the date of entry into force of this Regulation, have completed, within three months, the operations of the safety level 3 or 4 which have already been notified or approved. The entry into force of this Regulation shall be subject to a non-operational contingency plan, unless the notified or approved genetic engineering work has been completed. Unofficial table of contents

Section 10 Entry into force

This Regulation shall enter into force on the day after the date of delivery. Unofficial table of contents

Final formula

The Federal Council has agreed.