Part B of the application form is by default confidential. Part A of the application is public, but certain information can be kept confidential for a limited number of reasons, following a substantiated request and if a public summary of the confidential information is made available.
Can data that are included in Part A of the application be kept confidential?
Yes. Under certain conditions, data in a permit application may be kept confidential. European and Dutch policy aims to provide third parties with the most complete information possible about the application and the associated aspects. One of the most important points is that the risk analysis must be understandable for the general public based on disclosed information. As a result, together with the applicant an attempt is made to keep the amount of confidential information to a minimum. Moreover, this data and its provision must comply with a number of criteria.
Information that must always be disclosed
Article 25 of Directive 2001/18/EC indicates that the general description of the GMOGenetically Modified Organism and the environmental risk assessment must never be kept confidential. The application form and the environmental risk assessment must be readable as a separate documents. No confidential information or references to such information can be included or referred to in these components. Confidential information should be provided in a separate annex and a disclosed description of this information must be present in the application.The following information cannot be kept confidential:
- Name and address of the applicant.
- The general characteristics of the GMOs (please note that the following information can be kept confidential: strain designation (although the relevant characteristics of the strain must be disclosed); the name of the gene if this concerns a new use of a known gene; the exact base pair composition of the gene; and the exact modification of a gene (although the function of the modification must be disclosed).
- The aim of the release and the intended uses (anticipated uses that are not covered by the current permit application may be kept confidential).
- The location of the introduction, methods and plans for monitoring the GMO(s), and the emergency measures.
- Environmental risk assessment. The complete risk analysis and the applicant’s risk management proposal must be disclosed. Data that are important for this analysis (such as the route of administration of a GMO, the method of release and inactivation of material that contains GMOs) must also be disclosed. For the public dossier, however, a general description will often be sufficient; details of the experimental design and similar aspects are not essential.
In Part A of the application form, can I refer to confidential documents?
No. In Part A you cannot refer to confidential documents such as the Investigational Medicinal Product Dossier (IMPDInvestigational Medicinal Product Dossier ) or the clinical protocol. The application form is part of the environmental risk assessment and must be publicly available. One possibility is to make the confidential documents public. A second possibility is to retain the confidentiality of the documents, and in the application to refer to a public summary of these documents. The public summary must address the aspects that are relevant to the environmental risk assessment.
Substantiated request for confidentiality
The State Secretary for Infrastructure and the Environment can keep information confidential only under the following conditions:
- a substantiated request for confidentiality has been submitted to him/her, and
- a second text, which he/she has approved, is submitted in which the confidential information is not present or from which that information cannot be derived
Regarding release into the environment, the State Secretary should use this competence only if the disclosure of this information would have an adverse effect on competitiveness (trade secrets).
Regarding release into the environment, these considerations are based on Article 25.2 of Directive 2001/18 together with Article 19.3 of the Environmental Management Act and Article 10 of the Freedom of Information Act.
For permit applications to release GMOs into the environment, European Directive 2001/18/EC is followed, as implemented in the Decree on Genetically Modified Organisms 2013. According to Article 9 of this Directive, members of the public must be given an opportunity to voice their concerns about the proposed work. The procedure to be followed for permit applications to release GMOs into the environment is based on the General Administrative Law Act. This procedure gives everyone the opportunity to voice their concerns about the draft decision. For this purpose the dossier and the draft decision are made public, except for components of the dossier that have been identified by the applicant as confidential information.
Before submitting such a request, it is advisable to contact the GMO Office (Bureau GGO). If it is not possible to keep the information confidential, then a solution will be sought in consultation with the applicant.
Access to confidential data
The confidential data are accessible only by officials who are involved in the implementation of the GMO Decree, members of COGEMNetherlands Commission on Genetic Modification and, if necessary, the Administrative Court. An applicant can make a substantiated request asking that specific COGEM members are not given access to confidential information.
Article 2:5 of the General Administrative Law Act stipulates that everyone who is involved in performing the tasks of an administrative body, and in this capacity has access to information that can be reasonably assumed to be confidential, must respect this confidentiality. An exception to this provision is the information that must be disclosed by law. The confidentiality of information ends at the moment the applicant publishes this information. The applicant must report this publication to the State Secretary.