Does the standard environmental risk assessment apply?
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The GMO Genetically Modified Organism Regulation 2013 states that, if the application of naked DNA meets certain preconditions, the permit applicant may use an environmental risk assessment drawn up in advance by the Minister. These preconditions, among other things, include that administration of the naked DNA remains limited to tattooing or direct injection into the skin or striated muscle tissue. In addition, the naked DNA cannot contain viral sequences, with the exception of a CMV promoter, an RSV promoter, an SV40 polyadenylation signal or an SV40 nuclear targeting sequence. These DNA sequences and the related environmental risk assessment have been included in the standard environmental risk assessment.
This standard environmental risk assessment was published on 30 April 2014, as a background document, together with the Dutch GMO Environmental Management Act and the Regulation on genetically modified organisms 2013.