Biosafety Rules and Regulations of Bhutan 2018.

These Rules and Regulations (Regulations) are made in exercise of the powers conferred by Section 56 of the Biosafety Act of Bhutan 2015 (Act). Chapter I contains the scope of these Regulations and the activities that are prohibited. Chapter II provides for the composition of the National Biosafety Board established under the Act, its functions and related provisions. The functions of the Bhutan Agriculture and Food Regulatory Authority in respect of Biosafety are also laid down. Chapter III requires applicants to undertake risk assessment and propose risk management mechanisms. Chapter IV contains procedure for approval of activities involving GMOs.
Chapter V requires obtaining a permit for import of GMOs and its products for direct use as food, feed or for processing. It also provides for the procedures regarding export of GMOs. Chapter VI contains provisions relating to inspection and monitoring and Chapter VII lays down the labelling requirements. Chapter VIII provides for seizures and destruction of items not in compliance with these Regulations. Chapter X describes the liabilities involving GMOs and the offences and penalties. Chapter XI provides for the procedure for compensation and remedy in respect of harm caused by GMOs.