Authority for the Environment, Climate, Energy and Agriculture

Apply for a permit to build and operate genetic engineering facilities

Prerequisites

You will receive permission to set up and operate genetic engineering facilities if

• You, as the operator of the plant, as well as the persons responsible for the construction, management and supervision of the operation of the plant are reliable,
• the project manager and the person responsible for biosafety have the necessary expertise and are able to fulfil their obligations on a permanent basis,
• the facilities necessary for the required safety level according to the state of the art in science and technology are available,
• You fulfil the obligations for carrying out the intended genetic engineering work (general due diligence and record-keeping obligations, hazard prevention according to Section 6 Paragraphs 1 and 2 of the Genetic Engineering Act and the legal regulations according to Section 30 Paragraph 2 Numbers 2, 4, 5, 6 and 9 of the Genetic Engineering Act),
• You have taken precautions against harmful effects on the following legal interests:
  • Consideration of ethical values,
  • Life and health of people,
  • the environment in its causal structure,
  • Animals, plants and goods,
• They comply with the provisions of Article 2 of the Act of 21 February 1983 on the Convention of 10 April 1972 on the Prohibition of the Development, Production and Stockpiling of Bacteriological (Biological) and Toxin Weapons and on their Destruction (Federal Law Gazette 1983 II p. 132) and
• comply with the provisions prohibiting biological and chemical weapons in the implementing law to Article 26 paragraph 2 of the Basic Law (Law on the Control of War Weapons in the version promulgated on 22 November 1990 (Federal Law Gazette I p. 2506), last amended by Article 17 of the Law of 21 December 1992 (Federal Law Gazette I p. 2150)) and
• You take into account other public law interests as well as concerns of occupational health and safety and infection control.

Documents required

• written or electronic application
• other documents required for the project to check the requirements, such as
• 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
  • of the greenhouse/climate chamber
  • of the animal rooms and, if applicable, description of the shielding of the animal facility
• Copy of the operating instructions according to § 17 paragraph 2 GenTSV
• Copy of the hygiene plan according to § 17 paragraph 3 GenTSV
• Copy of the skin protection plan according to Annexes 2 to 4 GenTSV
• if applicable, flow chart according to EN ISO 10628
• where applicable, a programme for the successful control of plant diseases, weeds, arthropods and rodents pursuant to Section 15 in conjunction with Annex 3, Section I b, No. 3; Section II b, No. 5 GenTSV
• if necessary, proof of effectiveness of autoclave procedure
• where appropriate, proof of effectiveness of inactivation by chemical processes
• Documents proving the expertise and reliability of the project manager and the person responsible for biological safety
• Documents that prove the expertise and reliability of your relevant employees
• If applicable, proof of the non-profit status of the operator

Please note

Deadlines

You need the permit before you can start constructing or operating the genetic engineering facilities.

Procedure

They apply for permission to construct and operate genetic engineering facilities in writing.

You submit the application and the required documents to the responsible authority.

The responsible authority will examine your application and, if necessary, request documents or information from you.

If necessary, a hearing appointment will be made for you.

The responsible authority will decide on your application.

You will receive a notification.

Processing time

The processing time varies depending on the type of procedure.


If all the required documents and the safety classification by the Central Commission for Biological Safety are available, the responsible body will decide on your application for approval within 90 days.

Fees

Fees are charged in accordance with the environmental fee regulations. The amount may depend on the value of the genetic engineering facility. You can find out the exact amount in advance from the responsible authority.

Legal remedies

Objection within one month after receiving the decision

Legal basis

§ 8 Law on the Regulation of Genetic Engineering (GenTG)


https://www.gesetze-im-internet.de/gentg/__8.html




§ 10 Law on the Regulation of Genetic Engineering (GenTG)


https://www.gesetze-im-internet.de/gentg/__10.html




§ 11 Law on the Regulation of Genetic Engineering (GenTG)


https://www.gesetze-im-internet.de/gentg/__11.html




Genetic Engineering Safety Ordinance (GenTSV)


https://www.gesetze-im-internet.de/gentsv_2021/index.html




Genetic Engineering Procedure Ordinance (GenTVfV)


https://www.gesetze-im-internet.de/gentvfv/index.html