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Applying for a permit for the construction and operation of genetic engineering facilities

Source: Zuständigkeitsfinder Schleswig-Holstein (Linie6Plus)

Service Description

As the operator of a genetic engineering facility, you must notify, register or obtain approval from the competent authority for the construction and operation of the facility and other genetic engineering work, depending on the safety level.

Genetic engineering facilities of safety levels 1 to 4 are facilities in which genetic engineering work is carried out in a closed system in order to limit the contact of the organisms used with humans and the environment and to ensure a level of safety appropriate to the hazard potential.

Genetic engineering work may only be carried out in genetic engineering facilities. As the operator of a genetic engineering facility, you must notify, register or obtain approval from the competent authority for the construction and operation of the facility as well as other genetic engineering work, depending on the safety level. The competent authority will confirm receipt of the application without delay.

Whether the procedure involves notification, registration or approval depends on the safety level to which the intended genetic engineering work falls.

The construction of genetic engineering facilities is subject to

  • in which safety level 1 work is carried out is subject to a notification procedure
  • in which work of safety level 2 is carried out is subject to a notification procedure (in deviation from this, a permit can also be applied for)
  • in which work of safety level 3 and 4 is carried out, an authorization procedure.

The classification of genetic engineering work into safety levels is based on the assessment of the properties of the donor organism and the

  • of the donor organism and the nucleic acid segment intendedfor transformation ,
  • the recipient organism,
  • the vectors (genetic engineering tools used to introduce foreign DNA into a cell. These can be viruses, phages or plasmids),
  • the genetically modified organism (GMO).

The overall risk assessment is based on the interaction of all these factors.

In addition to the construction of a genetic engineering facility, every significant change to the facility is also subject to an official procedure corresponding to the safety level. Significant changes generally include changes to the scope or mode of operation of a genetic engineering facility.


Process flow

Notification/registration/approval of the construction and operation of or significant changes to genetic engineering facilities S1-S4:

As the operator, you must notify or register the planned first-time genetic engineering work and the construction or operation or significant changes to a genetic engineering facility S1 - S4. Once the notification has been received by the authority, you can only start work directly at safety level 1. Subsequent requests may be made and you may be asked to submit further documents and information. You will then receive a confirmation of receipt with these possible statuses:

  • Application in order,
  • Application with additional request,
  • Application with reasons for refusal.

You will then have the opportunity to attend a hearing with a draft decision and finally receive the decision, including a fee notice if applicable.

Competent authority

Department of Legal Affairs, Genetic Engineering at the Ministry of Energy Transition, Climate Protection, Environment and Nature of the State of Schleswig-Holstein

Requirements
  • Reliability of the operator and other responsible persons
  • Expertise of the above-mentioned persons
  • Fulfillment of duties
  • Security levels and appropriate precautions to ensure that no harmful effects on legal interests are to be expected
  • No conflicting prohibitions under the War Weapons Control Act
  • Other public law regulations and occupational health and safety occupational health and safety must not conflict with the construction and operation of the genetic engineering facility
Which documents are required?

Notification of a facility for genetic engineering work of safety level 1:

  • Proof of the operator's non-profit status, if applicable
  • Project manager and biosafety officer expertise (e.g. degree certificate and proof of professional experience in the form of a reference)
  • If the project manager does not belong to the company, then proof of a written agreement with the project manager, the operator and the third party in accordance with § 28 Para. 6 GenTSV
  • Copy of the operating instructions in accordance with § 17 Para. 2 GenTSV
  • Copy of the hygiene plan in accordance with § 17 Para. 3 GenTSV
  • Copy of the skin protection plan in accordance with Annexes 2 to 4 GenTSV
  • Site plan, construction drawings and furnishing or layout plan showing the location of the laboratory area and social rooms
  • Proof of efficacy of the autoclaving process, if applicable
  • Proof of efficacy of inactivation by chemical processes, if applicable

Notification/registration/approval in accordance with the Genetic Engineering Act at safety levels 2 to 4

  • Proof of non-profit status of the operator, if applicable
  • Project manager and biosafety officer expertise (e.g. degree certificate and proof of professional experience in the form of a job reference)
  • Site plan, construction drawings and furnishing or layout plan showing the location of the social rooms and
  • the laboratory area and/or
  • the production area and/or
  • the greenhouse/climate chamber
  • of the animal rooms and, if applicable, description of the shielding of the animal facility
  • Copy of the operating instructions in accordance with Section 17 (2) GenTSV
  • Copy of the hygiene plan in accordance with § 17 Para. 3 GenTSV
  • Copy of the skin protection plan in accordance with Annexes 2 to 4 GenTSV
  • Flow diagram according to EN ISO 10628, if applicable
  • If applicable, program for the successful control of plant diseases, weeds, arthropods and rodents in accordance with § 15 in conjunction with Annex 3 Sect. I b No. 3; Sect. II b No. 5 GenTSV
  • Proof of efficacy autoclaving method, if applicable
  • Proof of efficacy inactivation by chemical processes, if applicable
What are the fees?

Is based on the respective administrative fee schedule of the federal state or on the fee statutes of the authorities responsible under federal state law.

What deadlines do I have to pay attention to?

Before setting up and operating the genetic engineering facility, the operator must notify the competent authority, register it or have it approved.

Notification procedure:

Once the notification has been received by the authority, you can only start work immediately for safety level 1. Subsequent requests may be made and you may be asked to submit further documents and information. You will then receive a confirmation of receipt with these possible statuses: Application in order, with additional request for documents or with reasons for failure.

Application procedure:

The operator may start setting up and operating the genetic engineering facility and carrying out the initial genetic engineering work 45 days after receipt of the notification by the competent authority or earlier with the latter's consent. The expiry of the deadline is deemed to be consent to the establishment and operation of the genetic engineering facility and to the performance of the genetic engineering work.

Authorization procedure:

A decision on an application for approval must be made in writing within a period of 45 or 90 days.
The deadlines are suspended while the authority awaits the completion of the documents or until the required statement from the Commission on the safety classification of the planned genetic engineering work and the necessary safety measures has been received

Legal basis
Appeal
  • Appeal (depending on national law, the appeal may be excluded)
  • Administrative court action
Applications / forms
  • Written form required: yes
  • Personal appearance required: no
What else should I know?
Author

The text was automatically translated based on the German content.

Teaser

As the operator of a genetic engineering facility, you must notify, register or obtain approval from the competent authority for the construction and operation of the facility and other genetic engineering work, depending on the safety level.

Process flow

Notification/registration/approval of the construction and operation of or significant changes to genetic engineering facilities S1-S4:

As the operator, you must notify or register the planned first-time genetic engineering work and the construction or operation or significant changes to a genetic engineering facility S1 - S4. Once the notification has been received by the authority, you can only start work directly at safety level 1. Subsequent requests may be made and you may be asked to submit further documents and information. You will then receive a confirmation of receipt with these possible statuses:

  • Application in order,
  • Application with additional request,
  • Application with reasons for refusal.

You will then have the opportunity to attend a hearing with a draft decision and finally receive the decision, including a fee notice if applicable.

Competent authority

Department of Legal Affairs, Genetic Engineering at the Ministry of Energy Transition, Climate Protection, Environment and Nature of the State of Schleswig-Holstein

Requirements

  • Reliability of the operator and other responsible persons
  • Expertise of the above-mentioned persons
  • Fulfillment of duties
  • Security levels and appropriate precautions to ensure that no harmful effects on legal interests are to be expected
  • No conflicting prohibitions under the War Weapons Control Act
  • Other public law regulations and occupational health and safety occupational health and safety must not conflict with the construction and operation of the genetic engineering facility

Which documents are required?

Notification of a facility for genetic engineering work of safety level 1:

  • Proof of the operator's non-profit status, if applicable
  • Project manager and biosafety officer expertise (e.g. degree certificate and proof of professional experience in the form of a reference)
  • If the project manager does not belong to the company, then proof of a written agreement with the project manager, the operator and the third party in accordance with § 28 Para. 6 GenTSV
  • Copy of the operating instructions in accordance with § 17 Para. 2 GenTSV
  • Copy of the hygiene plan in accordance with § 17 Para. 3 GenTSV
  • Copy of the skin protection plan in accordance with Annexes 2 to 4 GenTSV
  • Site plan, construction drawings and furnishing or layout plan showing the location of the laboratory area and social rooms
  • Proof of efficacy of the autoclaving process, if applicable
  • Proof of efficacy of inactivation by chemical processes, if applicable

Notification/registration/approval in accordance with the Genetic Engineering Act at safety levels 2 to 4

  • Proof of non-profit status of the operator, if applicable
  • Project manager and biosafety officer expertise (e.g. degree certificate and proof of professional experience in the form of a job reference)
  • Site plan, construction drawings and furnishing or layout plan showing the location of the social rooms and
  • the laboratory area and/or
  • the production area and/or
  • the greenhouse/climate chamber
  • of the animal rooms and, if applicable, description of the shielding of the animal facility
  • Copy of the operating instructions in accordance with Section 17 (2) GenTSV
  • Copy of the hygiene plan in accordance with § 17 Para. 3 GenTSV
  • Copy of the skin protection plan in accordance with Annexes 2 to 4 GenTSV
  • Flow diagram according to EN ISO 10628, if applicable
  • If applicable, program for the successful control of plant diseases, weeds, arthropods and rodents in accordance with § 15 in conjunction with Annex 3 Sect. I b No. 3; Sect. II b No. 5 GenTSV
  • Proof of efficacy autoclaving method, if applicable
  • Proof of efficacy inactivation by chemical processes, if applicable

What are the fees?

Is based on the respective administrative fee schedule of the federal state or on the fee statutes of the authorities responsible under federal state law.

What deadlines do I have to pay attention to?

Before setting up and operating the genetic engineering facility, the operator must notify the competent authority, register it or have it approved.

Notification procedure:

Once the notification has been received by the authority, you can only start work immediately for safety level 1. Subsequent requests may be made and you may be asked to submit further documents and information. You will then receive a confirmation of receipt with these possible statuses: Application in order, with additional request for documents or with reasons for failure.

Application procedure:

The operator may start setting up and operating the genetic engineering facility and carrying out the initial genetic engineering work 45 days after receipt of the notification by the competent authority or earlier with the latter's consent. The expiry of the deadline is deemed to be consent to the establishment and operation of the genetic engineering facility and to the performance of the genetic engineering work.

Authorization procedure:

A decision on an application for approval must be made in writing within a period of 45 or 90 days.
The deadlines are suspended while the authority awaits the completion of the documents or until the required statement from the Commission on the safety classification of the planned genetic engineering work and the necessary safety measures has been received

Legal basis

Appeal

  • Appeal (depending on national law, the appeal may be excluded)
  • Administrative court action

Applications / forms

  • Written form required: yes
  • Personal appearance required: no

What else should I know?

Author

The text was automatically translated based on the German content.

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