ADVOKS GLOBAL · KENYA
The Biosafety (Environmental Release) Regulations
10. Validity and renewal of approval
Edition: 2022-12-31 · In force
10. Validity and renewal of approval
(1)An approval granted under these Regulations shall be for a period not exceeding ten years.(2)At least nine months before the expiry of an approval period, a person intending to continue to release into the environment or placing genetically modified organisms on the market shall submit an application for the renewal of the approval.(3)An application for renewal of an approval under these Regulations shall contain the information set out in the First Schedule to these Regulations and shall be accompanied by—(a)an application fee of eight hundred and fifty thousand shillings;(b)a copy of the approval under regulation 9(1);(c)a report on the results of the monitoring which was carried out in accordance with these Regulations;(d)any new information which has become available with regard to the risks of the genetically modified organism to human health and the environment; and(e)a proposal for amending or complementing the conditions of the original approval and any other conditions concerning future monitoring.(4)The Authority shall consider an application for renewal within thirty days of receiving the application and may—(a)approve the application with or without conditions; or(b)reject the application stating the reasons for rejection.(5)Pending the renewal of an approval, an applicant may continue operating under the conditions of approval granted under regulation 9(1) until a final decision has been taken on the application for renewal.(6)An approval for renewal from the Authority shall be valid for a period of ten years.(7)Where a genetically modified organism has been released into the environment or placed on the market for twenty years with the approval from the Authority, and the Authority establishes that monitoring data indicates no risk to human health and the environment, the genetically modified organism may continue to be released to the environment or placed on the market without further approval.