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Genetically Modified Organisms Act, 1997 (Act No. 15 of 1997)

Regulations

Genetically Modified Organisms Regulations, 2010

8. Registration of a facility

 

(1)        All facilities conducting activities shall be registered with the registrar.

 

(2)        An application for the registration of a facility shall be submitted to the registrar on a form that is obtainable from the office of the registrar.

 

(3)        A separate application shall be lodged with the registrar in respect of each facility and each such application shall include, but is not limited to—

(a)        the name of the person taking responsibility for the facility,

(b)        a map of the facility that indicates the different units within the facility,

(c)        a locality map that clearly indicates where the facility is situated, including its geographic coordinates,

(d)        a science-based risk assessment of the activity(ies) within the facility,

(e)        proposed risk management mechanisms, measures and strategies; and

(f)        the prescribed fee.

 

(4) The registrar shall approach the Advisory Committee for consideration of the application and a recommendation.

 

(5) Upon registration of a facility, the registrar shall furnish the applicant, with proof of registration and information on relevant guidelines.

 

(6) Registration of a facility shall be valid for a period of three (3) years, upon which the person referred to in paragraph (a) of sub-regulation (3) must apply for renewal of the registration.

 

(7) The person responsible for the facility shall, inter alia in hard copy format, keep and maintain the certificate of registration referred to in sub-regulation (6) and all records pertaining to risk assessment and risk management.

 

(8) The certificate and records referred to in sub-regulation (7) shall, upon request, be made available to the registrar or an inspector within the period specified by the registrar.

 

(9) The person responsible for the facility must notify the registrar of any change to the information provided in terms of this regulation.

 

(10)        Upon receipt of any change referred to in sub-regulation (9), the registrar may require the person responsible for the facility to submit a new application.