Regulation on the Central Commission for Biological Safety (ZKBS-Regulation-ZKBSV)

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ZKBSV

Date of completion: 30.10.1990

Full quote:

" ZKBS-Regulation as amended by the Notice of 5 August 1996 (BGBl. 1232), which was last amended by Article 354 of the Regulation of 31 December 2008. October 2006 (BGBl. 2407). "

Status:	New by Bek. v. 5.8.1996 I 1232;
	Last amended by Art. 354 V v. 31.10.2006 I 2407

For more details, please refer to the menu under Notes

Footnote

(+ + + Text evidence from: 8.11.1990 + + +) 

  

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§ 1 Tasks

(1) The Central Commission for Biological Safety (Commission) examines and evaluates safety-related issues in accordance with the provisions of the Gentechnikgesetz (Genetic Engineering Act), provides recommendations and advises the Federal Government and the Länder in (2) The Commission shall deliver opinions in accordance with the provisions of this Regulation, in particular with regard to the competent authority in accordance with the Genetic Engineering Act.

1.

on the safety classification of the proposed genetic engineering works and on the necessary security measures in accordance with § 7 of the Gentechnikgesetz (Genetic Engineering Act) and

2.

on the possible dangers to the legal goods referred to in § 1 (1) of the Genetic Engineering Act by the release or placing on the market of genetically modified organisms.

The Commission publishes general opinions on frequently carried out genetic engineering work with the underlying criteria of comparability in the Federal Gazette (Bundesanzeiger) and states in accordance with Article 6 (3) sentence 2 of the Gentechnik-Safety Regulation, newly recognised biological safety measures are regularly published in the Federal Gazette (Bundesanzeiger). (3) The Commission is consulted

1.

on the updating of the lists of organisers published by the Federal Ministry of Food, Agriculture and Consumer Protection in accordance with Article 5 (6) of the German Genetic Engineering Safety Ordinance (Bundesanzeiger) and

2.

on the scientific findings to be published by the Federal Ministry of Labour and Social Affairs in the Bundesworksheet in conjunction with Section 12 (8) in conjunction with Annex VI, Section E, of the Genetic Safety Regulation, which are published in the framework of the Medical check-ups should be taken into account.

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§ 2 appointment of the members

(1) The Federal Ministry of Food, Agriculture and Consumer Protection convenes the members and the deputy members in consultation with the state governments in accordance with Section 4 (2) of the Gentechnikgesetz (Gentechnikgesetz). In the case of vocations in accordance with § 4 (1) sentence 2 No. 1 of the Gentechnikgesetz (Gentechnikgesetz), proposals of the German Science Council are to seek proposals from the areas mentioned in the case of vocations pursuant to § 4 (1) sentence 2 No. 2 of the Gentechnikgesetz. (2) Federal Ministry of Food, Agriculture and Consumer Protection makes the names of the members and of the deputy members in the Federal Gazette known. Unofficial table of contents

§ 3 Members and alternates

(1) The activity in the Commission shall be carried out on a voluntary basis. The members and the alternate members shall receive reimbursement of their travel expenses in accordance with the Federal Travel Law and a session compensation. (2) The members and the alternates may, by means of a written declaration, the Federal Ministry of Food, Agriculture and Consumer Protection will terminate their membership at any time. Unofficial table of contents

§ 4 Participation of other persons and bodies

(1) The Federal Ministries referred to in Article 4 (2) of the Gentechnikgesetz and the competent supreme state authorities have the right to send representatives to the meetings of the Commission and the working groups. (2) The Commission's decision shall be taken as a result of the decision of the Commission. the applicant or the notifier shall be admitted to the oral presentation before the Commission, in accordance with the Genetic Engineering Act and the expert appointed by him. Unofficial table of contents

§ 5 Chairman and Deputy

The members or, in their absence, their deputies shall elect a chairman and two deputies for a period of three years from the circle of members according to § 4 (1) sentence 2 no. 1 of the Gentechnikgesetz. Re-election is possible. Unofficial table of contents

§ 6 Rapporteur

(1) The requirements of the opinions of the Commission shall be distributed to two rapporteurs from among the members and their alternates. The rapporteurs shall draw up a summary of the documents and shall carry out a security classification in the light of the security measures provided for; they shall draw up other opinions. They shall report to the Commission. (2) The rapporteurs may make proposals to the Commission for the drawing up of experts in accordance with § 7. Unofficial table of contents

Section 7 Experts

In order to carry out its tasks, the Commission may hear experts, report opinions, carry out investigations by third parties, or entrust individual Members or alternates with the performance of certain tasks. Unofficial table of contents

§ 8 Office

(1) The Commission has its head office at the Federal Office for Consumer Protection and Food Safety. (2) The office shall carry out the Commission's current operations, including the preparation, forwarding and publication of the Commission's Decisions and supports the Commission, the working groups and the rapporteurs in the performance of their tasks. (3) The office shall accept the requests addressed to the Commission, the competent authority shall inform the competent authority of the application. Incompleteness of the applications without delay and shall ensure the timely Assessment of applications by the Commission. Unofficial table of contents

Section 9 Meetings of the Commission

(1) The meetings of the Commission shall be held at regular intervals. The meetings of the Commission shall be so frequent that decisions may be communicated to the competent authorities within the time limits laid down. (2) The Chairman shall convene the Commission and shall, on a proposal from the Commission, convene the Commission for each meeting. (3) The invitation, the agenda and the meeting documents shall be sent to the members and to the alternates at the latest one week before the meeting. Compliance with the deadline may be waived if at least two-thirds of the members agree. The Federal Ministries referred to in Section 4 (2) of the German Genetic Engineering Act and the competent supreme state authorities receive the invitation, the agenda and, on request, the meeting documents message. (4) Is a member of the participation , it shall immediately inform its deputy and the office of business. (5) At the request of a majority of the members of the Commission, an extraordinary meeting shall be invited. Unofficial table of contents

Section 10 Implementation of sittings

(1) Meetings shall not be public. The Vice-Presidents shall take part in the meetings. (2) The Chairman shall open, direct and close the meetings; he shall be responsible for the order. (3) The agenda shall be decided at the start of the sitting. The agenda may be supplemented by a decision of two-thirds of the members. (4) Members shall be entitled to vote, in the event of their prevention the alternates. (5) The participants shall be entitled to vote on the content of the sitting. to maintain secrecy. Unofficial table of contents

Section 11 Decision-making

(1) The Commission shall be quorum if all members are invited and at least ten voting members, of which at least six voting members are present in accordance with Section 4 (1) sentence 2 No. 1 of the Gentechnikgesetz. (2) The Commission may, on the basis of the unanimous opinions of the rapporteurs or the members of a working group,

1.

Opinions on the safety classification of a genetic engineering work of safety level 2 or of a genetic engineering work of safety level 3 comparable to a work already carried out by the Commission, or

2.

recommendations on a request for release or placing on the market which is comparable to an application already assessed by the Commission,

in the written procedure. The first sentence shall also apply to the final decision-making of an opinion already advised by the Commission. The decision shall be deemed to have been adopted if no more than two members of the Commission object to the office within a period of ten days after receipt of the decision documents. In the event of an objection, the Commission decides. (3) Overvoted Members may require a minority vote to be expressed in the publication or forwarding of opinions of the Commission. A minority vote shall be admissible if the Member rejects the opinion as a whole and the subject-matter of the minority vote has been introduced in the form of an application in the deliberation. The minority vote must be justified. On the basis of the explanatory statement, the individual considerations must be based on the rejection of the opinion. Unofficial table of contents

§ 12 Minutes of the sitting

1. The office shall prepare a minutes of the meeting, the place and time of the meeting, the items of advice, the results of the meetings and the reasons for their reasons, as well as the balance of votes, for each meeting. Minority vots are logged. An attendance register shall be attached to the minutes of the session. (2) In order to facilitate the preparation of the session, the Office may record the course of the session on the recording medium. The minutes shall be deleted immediately after the adoption of the minutes of the sitting. (3) The minutes shall be signed by the chairman of the Commission and by a representative of the office. (4) The office shall send the minutes of the meeting. Minutes of meetings to the members, the deputy members, the federal ministries referred to in § 4 (2) of the German Genetic Engineering Act and to the competent supreme state authorities. In so far as the applicant or the notifier and experts instructed by the applicant are to be heard in accordance with Article 4 (2), the competent authority shall receive the relevant extract from the minutes of the sitting. Unofficial table of contents

§ 13 Working Groups

(1) The Commission may, as appropriate, form working groups for certain tasks in accordance with § 7 of experts in accordance with § 7 of this Directive. In urgent cases, the chairman of the Commission shall also be empowered to form working groups, in agreement with his deputies. The Commission shall inform the Commission of this. (2) The Commission shall designate a spokesperson for each of the working groups who shall represent the results of the work in the Commission. In the case of the second sentence of paragraph 1, the Chairman shall be appointed by the Chairman in agreement with his/her deputies. (3) The working groups shall have the Commission's results on the business unit for consultation and decision-making. . § 4 (1), § 7 and 10 (1) and § 12 shall apply. Unofficial table of contents

Section 14 Cooperation with the competent authorities

(1) The Commission shall give an opinion in accordance with Article 1 (2) no later than six weeks after the notification of further genetic engineering works at the latest four weeks after receipt of the documents in relation to the competent authority in accordance with the Gentechnikgesetz. The period after sentence 1 shall be extended if a supplement to the documents is required and the time limit shall be laid down in accordance with Section 11 (5) sentence 3 or (6) sentence 3, § 12 (5) sentence 3 or § 16 (3) sentence 3 of the Gentechnikgesetz (Gentechnikgesetz). The opinion shall be justified. It shall contain the supporting recitals, the result of the vote and the minority votes. (2) (omitted) Unofficial table of contents

Section 15 Activity report and information to the public

(1) The Commission shall draw up an annual activity report published by the Federal Ministry of Food, Agriculture and Consumer Protection. (2) The Commission may, in a suitable manner, inform the public of the opinions expressed by but not before the completion of the relevant procedure in accordance with the Genetic Engineering Act. Unofficial table of contents

Section 16 Rules of Procedure

The Commission shall adopt its rules of procedure. The Rules of Procedure require the approval of the Federal Ministry of Food, Agriculture and Consumer Protection, which makes its decision in agreement with the Federal Ministries referred to in § 4 (2) of the Gentechnikgesetz (German Federal Ministry of Genetic Engineering). Unofficial table of contents

§ 17

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§ 18

(Entry into force)