GMO AMENDMENT BILL 13 March 2006

J.B. Jaftha

N. Rabuli

C. Booyse

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Section 1: DEFINITIONSAmend existing definitions

contained usegeneral releaseuser

Amend existing definitions for alignment with CPBaccident: unintentional transboundary movement

Provide new definitionsactivitybiosafetyBCHcommodity clearanceconditional general releaseConventionenvironmental impact assessmentextension permitProtocolreleasetransboundary movement

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Section 1: DEFINITIONS

“activity”“’activity’ means any activity with genetically modified organisms but is not limited to the importation, exportation, transit, development, production, release, distribution, [contained] use, storage and application of genetically modified organisms only”.

biosafety“’biosafety’ means the level of safety when risk management measures must be taken to avoid potential risk to human and animal health and safety and to the conservation of the environment, as a result of exposure to activities with genetically modified organisms, and ‘biological safety’ shall have a corresponding meaning”

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Section 1: DEFINITIONS

contained use “’contained use’ means the development, production, cultivation,

use, application, storage, movement, destruction or disposal of genetically modified organisms within a facility, installation or other physical structure, including a greenhouse, that are controlled by specific measures, including physical barriers, or a combination of physical barriers together with chemical or biological barriers or both, that effectively limit contact of the GMOs with humans, animals and the external environment and their impact on humans, animals and the external environment.”

commodity clearance‘commodity clearance’ means the authorisation to use [a] genetically

modified organisms as a food or feed, or for processing, but excludes the planting of a genetically modified organism as a [direct] release into the environment;

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Section 1: DEFINITIONS

“protocol”‘Protocol’ means the Cartagena Protocol on Biosafety to the

Convention [on Biological Diversity], that has been negotiated and adopted by the Parties to the Convention [on Biological Diversity], acceded to by the Republic on 14 August 2003; a copy of the Protocol is attached for information purposes.

transboundary movement’ ‘transboundary movement’ means the movement of a

genetically modified organism [across the boundaries of the Republic] from the Republic to another country or from another country into the Republic.”

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Section 1: DEFINITIONS

“user”“user’ means a person who conducts an activity with a

genetically modified organism.

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Section 3: Executive Council

Establishment of the EC as a juristic personEnables EC to institute legal action, e.g. recovery of costs

Section 3(1) There is hereby established a [council] juristic person

known as the Executive Council for Genetically Modified Organisms, which shall consist of not more than [eight] 10 members appointed by the Minister

Nominated by their respective departments Inclusion of DAC & DWAF Knowledge of policies and legislation in respective sectors

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Section 3: Objectives of the Executive Council

The council shall advise the Minister on all aspects concerning [the development, production, use, application and release of] activities relating to genetically modified organisms, and [to] ensure that [all activities with regard to the development, production, use application and release of] such activities [genetically modified organisms] are performed in accordance with [the provisions of] this Act

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Section 5 : Powers and duties of the Council

Powers & duties: Discretionary & Obligatory Obligatory “the Council shall….

- determine whether an applicant must submit an EIA in terms of NEMA- an assessment of the socio-economic consideration- approve activities- consider scientifically based risk assessments and proposed risk management measures- determine the conditions for reapplication (change in activities)- Procedures to be followed in case of accidents and contraventions- Advanced informed agreement procedure on user (new)- Advice and information to Minister- Notification procedures to the BCH, affected States in case of accident and unintentional transboundary movements

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Section 5 : Powers and duties of the Council

Discretionary “ The Council may……” - Consider public input, EIA, socio-economic impact- Authorise the Registrar to issue a permit- consult with the AC on issuance on extension permits- Approve and issue guidelines- Reconsider a decision in light of new and relevant scientific evidence- Co-opt expertise to Council for advice

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Section7: Meetings of the Council

Quorum: simple majority (50% plus one) Decision based on consensus No consensus: application or any matter requiring a

decision under this Act is refused or denied Mechanism for special meetings Strengthen attendance of meeting: alternate members to be

appointed by the Minister

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Section 9: Functions of the Registrar

Subject to instruction by the EC and Independent

Subject to instruction or conditions by the EC- Determine the conformity of an application

- Manage permits: Issue a permit or extension permitamend or withdraw

- Authorise an inspector to act

- Attend to any other matter

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Section 9: Functions of the Registrar continued

Independent actions- Maintain a register of facilities, trails sites- Arrange for inspections- Require cessation of activities- Submit documents to Council- Communicate with the BCH

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Section 10: Advisory Committee

Two members from public sector, knowledgeable in:- ecological matters and GMO- impact of GMOs on human and animal health

Other expertise may be co-opted Clause 8(b) of amendment Bill: The committee shall co-opt or invite written comments from knowledgeable persons ………

Section 11(2) of the principle ActThe committee may appoint subcommittees to deal with specific matters as required.

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Section 11: Functions of the Advisory Committee

Providing advise to the Minister, the Council, the Registrar, other Minister and appropriate bodies.

Co-opt or invite written comments from knowledgeable persons in the specific fields of science on any aspect of genetically modified organisms which lies within the Committee’s brief, to assist the Committee in performing its functions.

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Section 12: Funding

Remuneration of:- Any other person who may be included on the Council [section 3(2)(c)]- Invited knowledgeable persons co opted to serve on the Council [section 5 (2)(h)]- Members of the Advisory Committee- Members co-opted or invited to provide comments to AC

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Section 15: Inspectors

Inspector under authority of a warrant to:• To seize any appliance, book, statement, document or

GMO • To give notice to owner before any seizure• To dispose of or repatriate any GMO used or any

material or substance used, affected or potentially affected if such activity has an adverse impact on the environment or human or animal health

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Section 17: Determination of risks and liability

Users shall ensure that appropriate measures are taken to avoid damage

In case of damage, the user shall:- inform the Registrar immediately- consult with Registrar to cease, minimise and contain movement of GMO, eliminate source of damage and remedy effect of the damage

EC is empowered to take measures when user fails to take adequate measures to remedy the situation

User is liable New clause on the Recovery of Cost:

Arising from damageArising from actions taken by EC

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Section 18: Confidentiality

The section aims to protect the confidential business information of the applicant

Places an obligation on those involved in the administration of the Act to protect the CBI

The following is not regarded as confidential:-The general description of the GMO-The name and address of the applicant- The purpose of use- Summary of the risk assessments on environment, human and animal health

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Section 19: Appeals

Allows for 60 days for appointment of an Appeal Board Minister may extend for another 30 days Type of decisions an appeal board may take:

confirm, set aside, substitute or amend make an order as it deems fit to minimize a significant negative impact on the environment or human or animal health

In making a decision consider new scientific or technical evidence or any other information.

Decision to be communicated within 30 days after final decision has been taken

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Section 20: Regulations

Period within which a decision on an application must be taken

Prescribing the procedure to be followed for drawing up a scientifically based risk assessment, environmental impact assessmet, socio-economic conideration and risk management measuresMinister should not have sole discretion in determining when and what information would constitute a risk assessment, EIA and socio-economic impact assessment.

Content of information be supplied by the user in case of an accident to the Registrar, to the BCH

Information in terms of the Advanced Informed agreement

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Section 21: Offences and Penalties

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Long title of Act 15 of 1997

[International agreement] = Protocol