The Biosafety Act, 2012
(Act No……7……of 2012)
Arrangement Of Sections
1. Short title and date of commencement
Part II Institutional Arrangement
4. Competent Authority
6. National Focal Point
7. Establishment and composition of the National Biosafety Advisory Committee
8. Functions of the National Biosafety Advisory Committee
9. National Biosafety Registry
10. Functions of Registrar
Part III Notification And Authorisation Requirements
11. Notification requirements and procedures for contained use activities
12. Authorisation requirements for intentional introduction into the environment
13. Application procedures for intentional introduction into the environment
14. GMO for direct use as food, feed or processing
15. Confidential information
16. Acknowledgement and preliminary response
17. Unintentional introduction into the environment
18. Risk assessment and risk management
19. Decision-making and communication of decision
20. Simplified application and review procedures
21. Petition for exemption or simplified procedures
Part IV Review Mechanisms
22. Review of decisions
23. Right of appeal
Part V Safeguards
24. Monitoring and submission of new information
Part Vi Public Information, Awareness And Participation
26. Public awareness and participation
27. International information sharing
Part Vii Identification, Documentation And Labelling
28 Documentation for GMOs intended for contained use
29.Documentation for GMOs for direct use as feed or for processing
30. Documentation for GMOs intended for intentional introduction into the environment
31. Labelling of GMOs
Part VII Enforcement
33. Liability and redress
34. Offences and penalties
Part IX Implementation Measures
An Act to provide for the safe handling, transfer and use of genetically modified organisms and other matters incidental thereto.Enacted by the King and the Parliament of Swaziland
Part I Preliminary
Short title and date of commencement
1. (1) This Act may be cited as the Biosafety Act, 2012.
(2) This Act shall come into force on a date to be appointed by the Minister by notice in the Gazette.
2. In this Act, unless the context otherwise requires-
“applicant” means a person or country submitting an application, notification or petition pursuant to the provisions of this Act;
“biosafety” means the mechanisms for ensuring the safe handling, transfer and use of products of biotechnology;
“Biosafety Clearing House” means the information exchange mechanisms established under article 20 of the Cartagena Protocol on Biosafety;
“Cartagena Protocol” means the Cartagena Protocol on Biosafety to the Convention on Biological Diversity;
“Committee” means the National Biosafety Advisory Committee as established in terms of section 6;
“Competent Authority” means the Swaziland Environment Authority as designated in terms of section 4;
“contained use” means any operation or activity, undertaken within a facility, installation or other physical structure, which involves GMOs that are controlled by specific measures that effectively limit their contact with and their impact on the external environment and the general population;
“export” means the intentional transboundary movement from the area of national jurisdiction of the country to the area of national jurisdiction of another country;
“facility” means any place designated by the Competent Authority as a place where GMOs may be stored;
“genetically modified organism (GMO)” means any biological entity capable of replication or of transferring genetic material and includes plants, animals, micro-organisms, cell cultures and other vector systems in which the genetic material has been altered through modern biotechnology and other genetic modification which occurs through techniques such as-
a. recombinant nucleic acid techniques involving the formation of new combinations of genetic material by the insertion of nucleic acid molecules produce into a virus, bacterium, plasmid or other vector and their incorporation into host organisms in which they are capable of continued propagation;
b. the direct introduction into an organism of heritable material prepared outside the organism including microinjection, macro-injection and micro-encapsulation; and
c. cell fusion (including protoplast) or hybridisation where live cells with new combinations of heritable genetic material are formed through the fusion of two or more cells;
“import” means the intentional transboundary movement into the area of national jurisdiction of the country from the area of national jurisdiction of another country;
“intentional introduction to the environment” means any deliberate use of GMOs, subject to this Act, that is not contained use, but does not include GMOs imported for direct use for food or feed or for processing
“living modified organism” means any living organism that possesses a novel combination of genetic material obtained through the use of modern biotechnology;
“Minister” means the Minister responsible for environmental affairs;
“national focal point” means the Swaziland Environment Authority as designated in terms of section 5;
“operator” means any person in direct or indirect control of the living modified organism as authorised in terms of this Act, including inter alia the permit holder, person who placed the living modified organism on the market, developer, producer, notifier, exporter, carrier or supplier.
“placing on the market” means making a GMO available to third parties whether there has been monetary exchange or not;
“Registrar” means the person appointed as such in terms of section 8;
“risk assessment” means the evaluation of risk in accordance with the guidelines set out in the second schedule;
“risk to human health” means the potential impact on human beings as a direct result of an adverse effect on the conservation and sustainable use of biological diversity; and
“third party” means any other person not directly involved within a transaction.
3. This Act applies to the import, export, transit, contained use, release or placing on the market-
a. of any genetically modified organism whether intended for release into the environment, for use as a pharmaceutical, for food, feed or processing;
b. or a product of a genetically modified organism, except for pharmaceuticals subject to the Pharmacy Act, 1929
4. (1) The Swaziland Environment Authority, as established in terms of the Environment Management Act, 2002, is designated as the Competent Authority for the purpose of implementation and the administration of this Act and any regulations made pursuant to this Act.
(2). The Management Board of the Swaziland Environment Authority shall also serve as the Board for the Competent Authority.
(3). The primary functions of the Competent Authority are to-
(a). eceive, respond to and make decisions on notifications pursuant to section 10 and applications pursuant to section 12 in consultation with the National BiosafetyAdvisory Committee and in conformity with the requirements of this Act;
(b). establish administrative mechanisms to ensure the appropriate handling, dissemination and storage of documents and data in connection with the processing of applications and notifications and other matters covered by this Act;
(c). promote public awareness and education concerning the activities regulated under this Act, including through the publication of guidance and other materials that explain and elaborate on the risk assessment, risk management and authorisation process; and
(d). advise on and be responsible for the implementation of the national biosafety policy;
(e). identify priorities of scientific and technological research that shall enable the country to meet its national and international goals and priorities on biosafety;
(f). coordinate, monitor and supervise all sectoral activities that involve modern biotechnology and biosafety issues;
(g). ensure the integration of safe application of biotechnology on the national development planning and policy formulation in liaison with line ministries;
(f). consider such measures as may be necessary to avoid adverse effects on the environment, biological diversity, human health and on socio-economic conditions arising from a GMO;
(g). recommend measures necessary for the harmonisation of the plans and policies of various sectors that are involved in safe application of biotechnology; and
(h). generally administer and give effect to this Act.
National Focal Point
5. (1) The Swaziland Environment Authority shall serve as the National Focal Point.
(2) The primary functions of the National Focal Point are to-
(a). receive, process and respond to information and notifications from the Secretariat of the Cartagena Protocol; and
(b). facilitate international information sharing as set out in section 26.
6. (1) A Committee called the National Biosafety Advisory Committee is established for the purpose of conducting risk assessments and providing scientific and other technical advice and assistance to the Competent Authority.
(2).The Committee shall consist of officers not exceeding nine drawn from government agencies and independent institutions and having the qualifications as provided for in terms of the Fourth Schedule.
(3). The members of the Committee shall be appointed by the Minister for a term not exceeding three years which may be renewed.
7. (1) The Committee shall be responsible for-
(a. )conducting risk assessments;
(b). reviewing risk assessments provided in applications or notifications;
(c). reviewing risk management measures;
(d). recommending containment measures, limitations on the duration of authorisations, reporting mechanisms, remedial measures, monitoring procedures and other appropriate and scientifically sound condition and risk management measures;
(e). developing guidelines for the safe transport, confined trials and commercial release of GMOs and their products in line with accepted international standards;
(f). developing standards for occupational safety for workers involved with development, testing and release of GMOs and their products and processes;
(g). developing guidelines for safe disposal of waste and leftover planting material;
(h). developing guidelines for commercial release and marketing of GMOs and products thereof; and
(i). providing such other expert advice and assistance as the National Authority on Biosafety may request.
(2). The Committee may establish sub-committees that may be necessary for the furtherance of the objectives of this Act and designate chairpersons of any such committees, who shall be drawn from the members of the Committee.
(3). The Committee may appoint additional members to sub committees as may be required.
(4). The Committee may co-opt temporary non-voting expert advisors from scientific disciplines not otherwise adequately represented on the Committee and its subcommittees.
(5). Members of the Committee and its subcommittees and all advisors shall be required to disclose publicly any actual and potential conflicts of interest relating to any risk assessment or any other matter upon which the Committee is required to deliberate.
(7). Internal procedures for the operation of the Committee and its subcommittees shall be proposed by it and approved by the Competent Authority and such internal procedures shall provide for all matters necessary for the effective and transparent operation of the Committee and any sub-committees established and shall include, at the minimum, mechanisms and procedures for-
(a). designating chairpersons of the Committee and its subcommittees, appointing members of sub-committees and advisers and specifying rules of procedure for the Committee and its subcommittees, and for the participation of advisors in the Committee or its sub-committees;
(b). ensuring the absence of conflicts of interest among members of the Committee and its sub-committees in conformity with subsection (5); and
(c). ensuring the protection of confidential information as required by section 14 including a declaration that any information attained by virtue of membership in the Committee or a sub-committee, or appointment as an advisor to the Committee or a sub-committee, shall not be disclosed to others or used for any research, development or commercial purpose without the express written authorisation of the applicant identifying the information as confidential pursuant to section 14.
8. (1) There shall be a National Biosafety Registry, created within the Swaziland Environment Authority which shall be manned by a Registrar and such other staff as may be necessary.
(2) The Registrar shall be a person who has specialised training and qualifications in biotechnology.
9. The Registrar shall perform the following functions-
(a). receive and screen completeness of a GMO application;
(b). forward applications to the Committee;
(c). where an approval has been given, issue a permit prescribed by this Act;
(d). where the Registrar has ascertained or suspects on reasonable grounds that GMOs are being imported, produced or used contrary to the provisions of this Act or the conditions of an issued permit-
(i)serve a notice upon any person by whom or on whose behalf GMOs are being imported into, produced or used within the country for the removal of such GMOs to a place or facility and in a manner prescribed by the Competent Authority, and
(ii)authorise an inspector to destroy such GMO or cause it to be destroyed;
(e). maintain a database of all applications received as well as all modern biotechnology applications being run in the country including information relating to monitoring and evaluation;
(f). furnish an inspector with a certificate of appointment;
(g). require the cessation of any genetic modification activity at facilities where the provision of this Act or the conditions of a permit have not been or are not being complied with; and
(h). attend meetings of the Board of the Competent Authority whenever matters under this Act are dealt with.
10. (1) A person shall not conduct any contained use activities or import GMOs for contained use activities without prior submission of a notification to the Competent Authority as set out in this section
(2). A notification of intent to conduct contained use activities shall be submitted at least sixty calendar days before the activities covered by the notification are due to begin.
(3). The notification shall include-
11. (1) The following activities are prohibited unless authorised by the Competent Authority in conformity with this Act-
notification is factually correct;
12. (1) A person proposing to introduce a GMO into the environment or place it on the market shall submit to the Competent Authority an application that complies with the requirements of this section and describe the activities for which authorisation is sought, except as provided under section 19.
13. (1) A person shall not import a GMO for direct use as food, feed or for processing without prior submission, within the time prescribed in the regulations, of a notification, in writing, to the Competent Authority containing information specified in the third schedule and any other information as may be prescribed by the Competent Authority.
14. (1) The Competent Authority shall-
15. (1) The Competent Authority shall, upon receipt of an application submitted under section 12, immediately refer the application to the Committee for prompt screening for apparent completeness.
16. (1) An operator with knowledge of an unintentional or unauthorised introduction into the environment of a GMO subject to this Act that is likely to have significant adverse effects on the conservation or sustainable use of biological diversity, taking into account also risks to human health, shall, within twenty-four hours of when the operator knew of the introduction, notify the Competent Authority of the occurrence.
17. (1) The Competent Authority shall ensure that appropriate and adequate risk assessments are carried out for all activities that require authorisation under section 11.
18. (1) The Competent Authority shall, following receipt of the risk assessment report, make a decision concerning the authorisation requested in the application submitted under section 12.
19. (1) The Competent Authority may approve a facility, including an installation or other physical structure, for which further notification is not required under section 10 for designated types or classes of contained use activities conducted in conformity with applicable laws, regulations and good laboratory practice standards and procedures; and requirements for this purpose shall be established by regulation under section 34.
Act GMOs or categories of GMOs agreed pursuant to Article 7(4) of the Cartagena Protocol as being not likely to have adverse effects on the conservation and sustainable use of biological diversity.
20. (1) A person may petition the Competent Authority to exempt or to apply simplified procedures for GMOs or activities under section 19(2) or (3) at any time.