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

Regulations

Genetically Modified Organisms Regulations, 2010

3. Applications and decision-making

 

(1) An application shall be submitted, in hard copy and electronic format, to the registrar on the relevant application form, that is obtainable from the office of the registrar.

 

(2) Unless the contrary is stated elsewhere in these regulations, any application listed in column 1 of Table 1 of the Annexure shall be processed within the time period specified in column 2 of Table 1 of the said Annexure.

 

(3) An application referred to in sub-regulation (1) shall include the following—
(a) a scientifically-based risk assessment,
(b) proposed risk management measures,
(c) copy of public notice as required in terms of Regulation 9; and
(d) if so determined by the Council, an assessment, in accordance with the provisions of the National Environmental Management Act, 1998 (Act No. 107 of 1998) and any other applicable laws, of the impact of the proposed activity on the environment and an assessment of the socio-economic considerations of the activity.

 

(4) Where an applicant is required to conduct a public notification it shall be done in accordance with Regulation 9 and the application referred to in sub-regulation 3(1) shall be submitted to the Registrar prior to the notice being published.

 

(5) The applicable application fee specified in Table 2 of the Annexure shall accompany each application referred to in sub-regulation (1).

 

(6) The registrar shall, after receipt of an application referred to in sub-regulation (1)—
(a) acknowledge, in writing, receipt of such application within five (5) working days of such receipt; and
(b) examine the conformity of the application to the requirements of the Act and the provisions of these regulations; and—
(i) if the application does not conform to the requirements of the Act and the regulations in any respect, refer the application back to the applicant, indicating the deficiency in the application; or
(ii) if the application conforms to the requirements of the Act and the regulations, submit the application to the Committee and/or Council for consideration.

 

(7) The Council may—
(a) approve an application referred to in sub-regulation (6)(b)(ii) and authorise the registrar in writing to furnish the applicant with the applicable permit to undertake the activity concerned on such terms and conditions as the Council considers necessary;
(b) refuse such application; or
(c) request additional information from the applicant, the registrar, the Committee or any person knowledgeable in a specific field of science.

 

(8) The Council shall provide reasons for any decision taken in terms of sub-regulation 7.

 

(9) An applicant shall immediately notify the registrar, both verbally and in writing, of any change in information provided in an application submitted in terms of this regulation, regardless of whether the such application has been considered under sub-regulation (7) or not.

 

(10) Upon receipt of any change referred to in sub-regulation (8) above, the registrar shall refer the details of such change to the Committee and/or Council which may require the applicant to submit a new application.

 

(11) The Council shall determine the terms and conditions under which the Registrar may issue an extension permit for an activity for which a permit has been issued previously.