The contained use of GMOs shall require consent from the minister competent for the environment. The application for consent for the contained use of GMOs with the additional documentation are submitted to the Minister of The Environment. The application for consent for the contained use of GMOs is covered by the annex 1 of the Regulation of the Minister of the Environment laying down the formats of application forms for consent and authorization of activities involving genetically modified organisms (OJ 2002 No. 87, Item 797). 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:
o information on the GMO user, business name and seat, or first and last name and address, and the first and last name of the person directly responsible for the planned contained use of GMOs, o information on planned activities including the characteristics of GMOs or of the combination of GMOs:
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host and recipient organisms used and the vector system used,
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the source and planned function of the genetic material used for modification,
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identifying features of the GMO,
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information on planned degrees and types of protection,
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information on safety measures for working with GMOs,
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information on planned method of GMO waste disposal.
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documentation of the risk assessment,
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the emergency plan.
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, icluding 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 assesement 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,
In the case of activities involving the contained use of GMOs, it shall be necessary to submit the result of the final classification of a GMO to a given class of risk and a description of the containment conditions required for a given class, taking particularly into account the issues of waste handling.
An emergency plan for response to an accident in the case of activities involving the contained use of GMOs:
The emergency plan should comply with the category of risk and include in particular: information on safety measures to be applied by the exposed persons in case of an emergency and information on methods of counteracting effects of uncontrolled dissemination of GMOs including information on activities to be undertaken by rescue teams. The GMO user shall provide the emergency plan to commune authorities, which within 7 days of the day the plan is received, shall make it available to the public in the manner as usually practised at the seat of the commune. In case of contained use of GMOs within risk category III or IV, the GMO user shall be obliged to agree the emergency plan with the competent voivode. The voievode shall present, by means of an administrative decision, objections to the emergency plan or confirm lack of such objections within 30 days of receiving the application. The emergency plan shall be available at the place of the contained use of GMOs. Additionally the risk assessment is checked in accordance with art. 6, 7, 8 of the Act on GMO and the 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. After verification the application is sent to the commission on GMO in the aim of preparation of an opinion. The commission assesses the information from application taking into account scientific point of view. 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. The Commission shall give opinions in form of resolution, which is adopted in an open vote. Resolutions shall be adopted by an ordinary majority of votes. 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. 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 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 by 30 days. The consent shall be granted for a definite period of time, not longer than five years upon establishment of all legally required conditions for the contained use of GMOs.
Additional information concerning the procedure of granting the consent for contained use of GMO:
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. 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. 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. In case of operations involving the contained use of GMOs within category I and II , the consent may be issued upon the application submitted by a GMO user who represents several units operating within his structures and performing the same type of research and operations involving GMOs. The application must conform to requirements of Section 21 of Act on GMO and the information contained therein must contain description of the type of research and type of activities involving GMOs. The Minister shall refuse to grant consent for category III and IV activities if he has reasons to believe that the safety measures shall not be sufficient to avoid severe or irreversible failures or risk of failure resulting from the intended method of the contained use of GMOs. In accordance with art. 25 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 contained use of GMOs within category III and IV shall include a security of claims resulting from potential damages. The form and amount of the claim security shall be specified in the consent for the contained use of GMOs. The security may take the form of a deposit, bank guaranty, or insurance policy. The GMO user in accordance with the art. 35 of Act on GMO shall be obliged to keep regular records and documentation of actions and to store them for a period of at least five years of the completion of the actions.
Revocation of the consent for contained use GMO:
The consent shall be revoked if:
the GMO user violates rules of the Act, fails to remove by set date the actual or legal status incompliant with the governing rules of the law, there are justified reasons to believe that the safety measures shall not be sufficient to avoid severe or irreparable failures, the risk of failure exceeds permissible risk limits.
Granting, refusal to grant, and revocation of the consent shall be done by means of an administrative decision, which shall be carried out immediately.
A subsequent contained use of GMO:
A subsequent contained use of GMOs by the same user, in case of GMOs accounted to hazard category I or II, at the same place and under the same conditions shall not require another consent for the contained use of GMOs, subject to art. 24 para 2 (art. 24 para 2 – “If it is ascertained that the activity was assigned to a lower hazard category than the category which in the light of gathered documentation it should have been, the GMO user may be requested to alter the classification of the activity category”.). The GMO user shall notify the Minister of a subsequent contained use of GMOs:
Within 2 months before planned contained use of GMOs, for activities accounted to hazard category I, Within 3 months before planned contained use of GMOs, for activities accounted to hazard category II. Notification of a subsequent contained use of GMOs shall comply to requirements which are covered by the application for the granting the consent on contained use of GMO.
Register of the Contained Use of GMOs:
Granted consent is registered in the Register of the Contained Use of GMOs.
The Register shall contain:
applications for the consent for the contained use of GMOs with accompanying documentation, notifications of the subsequent contained use of GMOs, consents for the contained use of GMOs with justification, the information on revocation or alteration of the consent, opinions of the Commission, information on failures.
The Register is open and the access to the Register shall be free of charge.
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