Deliberate release of GMO into environment for purposes other than placing them on the market

Procedure for obtaining consent for Deliberate release of GMO into environment for purposes other than placing them on the market:

  1. The deliberate release of GMO into environment for purposes other than placing them on the market shall require consent from the minister competent for the environment, granted upon the application of the interested party.

  2. The application for consent for the deliberate release of GMO into environment for purposes other than placing them on the market with the additional documentation are submitted to the Minister of The Environment.

  3. The application for consent for the deliberate release of GMO into environment for purposes other than placing them on the market is covered by the annex 2 of the Regulation of the Minister of the Environment laying down the formats of application forms for consent and authorisation of activities involving genetically modified organisms (OJ 2002 No. 87, Item 797).

  4. The application is registered in accordance with the office order compulsory in the Ministry, formally verified by the substantial unit competent for GMO issues. The following elements are usually checked:

    • information on the GMO user including his business name and seat, or the first and last name and address,

    • information on the GMO:

      1. description of the host, recipient, and parental organism if any,

      2. description of the vector,

      3. description of the GMO,

    • information on conditions of deliberate release of GMOs into the environment:

      1. information on conditions: place of deliberate release and broader environment to which the release shall be done,

      2. description of the purpose of intended release,

      3. description of the environment to which the release shall be done,

    • information on interactions between the GMO or combination of GMOs and the environment including the possibility of cross-breeding:

      1. description of environmental impacts on survival, culturing and propagation of the GMO,

      2. impact of the GMOs on the environment,

    • information on professional skills of the employees,

    • information on the procedure of audit and monitoring the process of GMO release into the environment and suggestions on spatial isolation:

      1. information on the monitoring technique,

      2. information on the audit of deliberate release into the environment,

      3. emergency response plans,

    • information on inactivation of GMOs and waste disposal,

    • information on results of the previous deliberate release of the same GMO or combination of GMOs into the environment that the applicant obtained consent for.

    • documentation of risk assessment and description of assessment methods,

    • technical documentation of deliberate release of GMOs into the environment,

    • emergency plan in case of danger to human health or environment.

The application shall include a summary of the application and accompanied documentation.

The documentation of the risk assessment:

The risk assessment shall be carried out in a manner verifiable against available scientific and technical data given direct and indirect hazards, which may occur in the short- and long-term, in accordance with requirements which are covered by Regulation of the Minister of the Environment laying down the detailed manner of carrying out the assessment of risks to human health and the environment related to the undertaking of activities involving the contained use of GMOs, the deliberate release of GMOs into the environment, including the placing of GMO products on the market, and the requirements which should be satisfied by the documentation containing the results of such an assessment (O J 2002, 107, 944). The documentation of the risk assessment shall consist of :

  • an assessment of the risks to human health and the environment, along with the related conclusions, including references to information contained in the applications for the consents,

  • a description of the methods used to perform an assessment of the risks to human health and the environment.

  1. After verification the application is sent to the commission on GMO in the aim of preparation of an opinion.

  2. The commission assesses the information from application taking into account scientific point of view.

  3. The commission verifies the risk assessment related to contained use of GMO taking into account potential risks for human health and the environment which may carry out the utilisation of the specific GMO. Before granting of the opinion, commission shall require an additional information or shall recommend preparation of an independent expertise.

  4. The Commission shall give opinions in the form of resolution, which is adopted in an open vote. Resolutions shall be adopted by an ordinary majority of votes.

  5. The consent for contained use of GMOs shall be issued within three months of the receipt of the application. Pending deadline shall be suspended if the application needs to be completed or additional information should be submitted.

  6. In the proceedings consisting in granting consent for the contained use of GMOs public participation is possible. The participation shall be regulated by rules on public environmental proceeding protection participation. In accordance to art. 24 para. 1a In case of public participation the deadline for the issue of consent for the enclosed use of GMOs referred to in subsection 1 shall be prolonged by the time of consultation, however, not longer than 30 days.

  7. The consent on deliberate release of GMOs into the environment is granted for the period which id described in the consent.

  8. The consent for deliberate release of GMOs into the environment at various locations specified in the consent or various combinations of GMOs at the same location may be granted at the same decision if the releases have the same purpose and take place at the time as specified in the decision.

Additional information concerning the procedure of granting the consent for contained use of GMO:

  1. Before the consent is granted information in the consent application may be checked to assess whether the applying GMO user meets the conditions for the contained use of GMOs described in the application.

  2. The applying GMO user may be requested, if necessary, to provide by a set date missing documentation to confirm that the applicant meets the conditions specified by the rules of the law for the contained use of GMOs.

  3. A request shall be made to the GMO user for additional information required for a thorough review of the case including opinion which will be prepared by the accredited laboratory on the applicant’s cost.

  4. For the sake of public interest of particular importance to protection of human health and the environment and in particular the risk of environment deterioration, the consent for the deliberate release into the environment shall include a security of claims resulting from potential damages.

Obligations that should be meet by the GMO user:

  1. If, following receipt of the consent, a change is introduced to preparations or the process of release of GMOs into the environment, which could endanger human health or the environment, or the applicant obtains information on such hazards, he shall be obliged to immediately notify the Minister of all new information on hazard to human health and the environment.

  2. Within ninety days of completion of activities, the GMO user who performs a deliberate release of GMOs into the environment shall be obliged to present the Minister a report with a detailed description of results of the release including information on all risks to human health or environment noticed in the course of deliberate release of GMOs into the environment.

Revocation of the consent for deliberate release of GMOs into the environment:

  1. In accordance with art. 39 of the Act on GMO The consent on deliberate release of GMOs into the environment may be revoked or amended if there is new information important for the assessment of hazards to human health or environment related to deliberate release of GMOs into the environment.

  2. Granting, refusal to grant, and revocation of the consent shall be done by means of an administrative decision, which shall be carried out immediately.

Register of the Register of Deliberate Releases of GMOs into the Environment:

Granted consent is registered in the Register of Deliberate Releases of GMOs into the Environment.

The Register of the Deliberate Releases of GMOs into the Environment shall contain:

  • applications for the consent for deliberate release of GMOs into the environment with attached documentation,

  • consent for deliberate release of GMOs into the environment with justification and information on revocation or alteration of the consent,

  • opinions of the Commission,

  • reports with a detailed description of results of the release including information on all hazards to human health or environment noticed in the course of deliberate release of GMOs into the environment which is submitted by the GMO user after deliberate release.


The Register is open and the access to the Register shall be free of charge.

 
© 2005 Ministry of the Environment