Biosafety (Amendment) Proclamation No.896 /2015.
Country
Type of law
Legislation
Abstract
This Proclamation (the Amending Proclamation) amends the Biosafety Proclamation No. 655/2009 (main Proclamation) in several articles. Sub-articles (1), (4), (6), (9), (12), (17) and (18) of Article 2 are deleted and replaced; sub-articles (19), (20), (21) and (22) are added after sub-article (18) of Article 2 of the Proclamation and the existing sub-articles (19) and (20) are re-numbered as sub-articles (23) and (24). These amendments entail that several definitions from the main Proclamation have changed (modified organism, contained use, advance informed agreement, etc.) and new concepts added (modern biotechnology, special permit). 'Modern biotechnology’ means the application of: a) In vitro nucleic acid techniques, including recombinant deoxyribonuclic acid and direct injection of nucleic acid into cells or organelles; b) fusion of cells beyond the taxonomic family; that overcome natural physiological, reproductive or recombination barriers and that are not techniques used in traditional breeding and selection.
Moreover the Amending Proclamation changes the objective of the Main Proclamation (new Article 4) to: 1) to protect human and animal health, biological diversity and in general, the environment, local communities and the country at large by preventing or at least managing down the adverse effects of modified organisms to levels of insignificance; and 2) enhance access to and transfer of technologies, including modern biotechnology, that serve for conservation and sustainable use of biological diversity.
A new discipline for advance inform agreement is contained in a new Art. 5, same is for a new discipline for special permit (new Art. 6). ‘special permit’ means a written permit granted by the Ministry for importation of a modified organism for contained use in research or teaching but not for release into the environment in accordance with this Proclamation. Article 9 of the Proclamation is deleted and replaced by new Article 9 that regulates Importation of Modified Organisms; importation of any modified organism without obtaining an advance informed agreement or a special permit is prohibited. A new Art. 17 contains validity period of advance informed agreement and special permit.
A new Artt. 22 and 23 establish the National Biosafety Advisory Committee, accountable to the Minister, and a Grievance Hearing procedure and Committee.
Moreover the Amending Proclamation changes the objective of the Main Proclamation (new Article 4) to: 1) to protect human and animal health, biological diversity and in general, the environment, local communities and the country at large by preventing or at least managing down the adverse effects of modified organisms to levels of insignificance; and 2) enhance access to and transfer of technologies, including modern biotechnology, that serve for conservation and sustainable use of biological diversity.
A new discipline for advance inform agreement is contained in a new Art. 5, same is for a new discipline for special permit (new Art. 6). ‘special permit’ means a written permit granted by the Ministry for importation of a modified organism for contained use in research or teaching but not for release into the environment in accordance with this Proclamation. Article 9 of the Proclamation is deleted and replaced by new Article 9 that regulates Importation of Modified Organisms; importation of any modified organism without obtaining an advance informed agreement or a special permit is prohibited. A new Art. 17 contains validity period of advance informed agreement and special permit.
A new Artt. 22 and 23 establish the National Biosafety Advisory Committee, accountable to the Minister, and a Grievance Hearing procedure and Committee.
Attached files
Web site
Date of text
Repealed
No
Source language
English
Legislation Amendment
No