Regulation on records in the case of genetic engineering works and releases (Genticnik recording ordinance-GenTAufzV)

Unofficial table of contents

GenTAufzV

Date of completion: 24.10.1990

Full quote:

" Genetic-recording Regulation as amended by the Notice of 4 November 1996 (BGBl. 1644), as last amended by Article 3 of the Regulation of 28 April 2008 (BGBl I). 766).

Status:	Recast by Bek v. 4.11.1996 I 1644;
	Last amended by Art. 3 V v. 28.4.2008 I 766

For more details, please refer to the menu under Notes

Footnote

(+ + + Text evidence from: 4.11.1990 + + +) 

  

Heading: IdF d. Art. 1 No. 1 V v. 4.11.1996 I 1642 mWv 9.11.1996 u. d. Art. 5 No. 1 G v. 16.8.2002 I 3220 mWv 24.8.2002 Unofficial table of contents

§ 1 Scope

Those who carry out genetic engineering work or releases shall keep records, keep records and submit them to the competent authority in accordance with the provisions of this Regulation. Unofficial table of contents

§ 2 Records in the case of genetic engineering works or releases

(1) The records of genetic engineering work must include the following information:

1.

the name and address of the operator and the location of the genetic engineering plant in which the genetic engineering works are carried out,

2.

the name of the project manager,

3.

the name of the person or agent responsible for the biosafety,

4.

in the case of genetic engineering work pursuant to § 8 (2) sentence 1, paragraph 4 sentence 2, § 9 para. 2 sentence 1 or section 4 of the Gentechnikgesetz (Genetic Engineering Act), the date of notification or notification of the genetic engineering works, in the case of genetic engineering work pursuant to § 9 para. 1, the date of the Inclusion of the genetic engineering work,

5.

the file number and date of the notification, the application or the approval certificate or the date of consent pursuant to section 12 (5) sentence 1 of the Gentechnikgesetz (Genetic Engineering Act),

6.

the security level,

7.

the date of commencement and the completion of the genetic engineering work;

8.

The nature of the starting organisms and the starting materials:

a)

organisms as donors of genetic information,

b)

Degree of purification of nucleic acids,

c)

Vector, if used,

d)

Characteristics of the recipient organism as far as they are relevant for the safety assessment of the genetic engineering works,

9.

for the safety level of significant characteristics of the genetically modified organism,

10.

in the case of genetic engineering work with human-pathogenic organisms of safety level 2, 3 or 4, the other persons involved in the direct implementation, and

11.

any incident which does not correspond to the expected course of the genetic engineering work and in which the suspicion of endangering the legal goods referred to in Section 1 (1) of the Genetic Engineering Act cannot be ruled out,

12.

Information on waste and waste water disposal.

The records must also contain the information on the risk assessment in accordance with § 6 (1) sentence 1 of the Gentechnikgesetz. This risk assessment must be carried out in accordance with the criteria laid down in Annex I to the Genetic Engineering Safety Regulation. (2) In the case of genetic engineering work in the laboratory sector, the following shall be recorded:

1.

in the case of further genetic engineering work of safety level 1, description of the genetic engineering work, including its objectives, and

2.

Changes in the security level, indicating the reasons for this and the point in time.

(3) In the case of genetic engineering work in the production sector, additional recording shall be made:

1.

Presentation of the principle of production and reprocessing, insofar as necessary for the protection of the legal goods referred to in Article 1 (1) of the Genetic Engineering Act, including the description of the product to be produced by the genetic engineering works,

2.

the equipment to be used in the manufacture of the equipment, the methods and equipment to be used for the day-to-day control of the manufacture (in-process control), and

3.

Number of approaches including the individual production volumes.

(4) In the case of genetic engineering work of security level 3 or 4, additional recording shall be carried out:

1.

the individual stages of work enabling the production of genetic engineering works, by time, content and persons directly involved,

2.

in the case of genetic engineering work in the laboratory field, the expected number of genetically modified organisms in the individual approaches, in each case at least in accordance with minimum and maximum levels, and in the case of micro-organisms or cell cultures, the expected number of volume of the largest single approach and

3.

in the case of genetic engineering work in the production sector, the number of genetically modified organisms in the individual approaches, in each case at least by minimum and maximum quantity.

(5) The records of releases must contain the following information:

1.

the name and address of the operator, the location of the release area and the occupancy of the parcels,

2.

the name of the project manager,

3.

The name of the Biological Safety Officer,

4.

the file number and date of the approval certificate;

5.

the date of the commencement and termination of the release,

6.

description of the released organisms, including genetic modification,

7.

the number or quantity of genetically modified organisms that have been put out;

8.

the fate of the genetically modified organisms after the end of the release;

9.

the number of genetically modified organisms stored on or in the vicinity of the release area in connection with the release plan;

10.

the place, the beginning and the end of storage,

11.

the date and result of the control operations,

12.

essential measures for the treatment of the release area and

13.

any incident which does not correspond to the expected course of the release and in which the suspicion of endangering the legal goods referred to in Section 1 (1) of the Gentechnikgesetz (Genetic Engineering Act) cannot be ruled out.

(6) The recording may, in the records referred to in paragraphs 1 to 5, refer to information in the filing or approval documents. (7) Where necessary, the records shall be kept up-to-date and up-to-date for the performance of the work or of the Release. The information in accordance with § 2 (1) sentence 2 shall be recorded before the start of the genetic engineering work. Unofficial table of contents

§ 3 Form of records

(1) The records shall not be made illegible either by deletion or by any other means. No changes may be made which do not indicate whether they have been made at the time of the original registration or only later. (2) The records may also be recorded on an image carrier or on other data carriers. and shall be kept in such a way as to ensure that subsequent changes to the content are not possible. When keeping records on data carriers, it is necessary to ensure, in particular, that the data are available during the retention period and can be made legible within a reasonable period of time. Paragraph 1 shall apply. (3) The records shall be signed by the operator, the project manager responsible or any person appointed by that person. Where the management and storage referred to in paragraph 2 are carried out, it shall be ensured that the clear assignment to the person responsible is ensured. Unofficial table of contents

§ 4 Recording and submission requirements, retention period

(1) The operator shall submit the records of the competent authority to the operator at its request. He shall keep the records; the retention periods shall be

1.

Ten years in the case of genetic engineering work of safety level 1,

2.

thirty years in the case of genetic engineering work of safety levels 2 to 4; and

3.

thirty years in the case of releases,

after completion of the genetic engineering work or the releases. (2) The operator can commission the project manager with the management of the recordings. (3) In the case of operating sedment, the operator of a genetic engineering plant has the records shall immediately be handed over to the competent authority, provided that the time limits referred to in paragraph 1 have not expired. Unofficial table of contents

§ 5 Administrative Offences

Contrary to the provisions of Section 38 (1) (12) of the Gentechnikgesetz (Gentechnikgesetz), anyone who intentionally or negligently acts as an operator

1.

, contrary to § 2 para. 1 sentence 1, para. 2, 3, 4 or 5 records, records are not properly or incompletely kept,

2.

, contrary to § 4 (1), records shall not be presented or not stored in due time or not, or kept for the prescribed period, or

3.

, contrary to Section 4 (3), records shall not be handed over to the competent authority in due time.

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§ 6

(dropped) Unofficial table of contents

§ 7

(Entry into force)