ADVOKS GLOBAL · KENYA
The Biosafety (Contained Use) Regulations
12. Handling of new information
Edition: 2022-12-31 · In force
12. Handling of new information
(1)A grantee who subsequently becomes aware of information which could have significant consequences for the risks posed by it, shall inform the Authority of such information as soon as possible.(2)A person who withholds any information that becomes available before and after the approval of the application, and which could reasonably be expected to change the evaluation of the risk posed by the activity, commits an offence and is liable on conviction to a fine not exceeding two million shillings or imprisonment for a term not exceeding ten years, or both.(3)Where information which could have significant consequences for the risks posed by the contained use, subsequently becomes available, the Authority may require the grantee to modify the conditions of, or suspend or terminate, the contained use.(4)A grantee, who wishes to request for an extension or to modify the contained use, may make a written request to the Authority and the Authority shall within thirty days acknowledge receipt of the request.(5)The Authority shall review the request and where it considers that the proposed extension or modification—(a)does not require risk assessment, the Authority shall communicate its decision within thirty days from the date of the receipt of the request; or(b)may have material effect on the outcome of the risk assessment upon which the decision was based, the Authority shall, if is satisfied that a change is warranted, make a decision within one hundred days from the date of the receipt of the request.