B4FA 2013 Ghana: Agricultural biotechnology and the regulatory environment - Josephine Nketsia-Tabiri

Prof. Josephine NKETSIA-TABIRI

Member, National Biosafety Committee

B4FA 13-16/3/2013 RR 1

Outline of Presentation • Introduction

Convention on Biological Diversity and the Cartagena Protocol on Biosafety

National Policy on Biotechnology /Biosafety

Regulation of Modern Biotechnology in Ghana

Development of National Biosafety Frameworks

L.I. 1887 Biotechnology Regulation 2007

Biosafety Law 831:2011

Conclusions

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Introduction

Convention on Biological Diversity (CBD) 29 Dec 1993

International Instrument for addressing biological diversity issues.

provides a comprehensive approach to the conservation of biological diversity, the sustainable use of natural resources and the fair and equitable sharing of benefits deriving from the use of genetic resources.

Recognizes the need for appropriate procedures to enhance the safe exploitation of biotechnology.

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Introduction

Cartagena Protocol on Biosafety to the CBD - Ghana ratified 30 May 2003

A legally binding international protocol for the transboundary movement of products of modern biotechnology.

National Biosafety Committee set up and mandated to develop guidelines for safe application of modern biotechnology in Ghana.

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Introduction A National Policy on Biotechnology /Biosafety

National Science, Technology & Innovation Policy (2010): On Increasing Agricultural productivity “..…promote the research and application of new technologies including safe biotechnology, which hold potential for increasing productivity”

Guided by Ghana’s 1992 Constitutional obligation to promote agriculture and industry and at the same time ensure protection of the environment and our natural resources [Art. 36 (9), 41 (k)].

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Regulation of Agric Biotechnology in Ghana

Development of National Biosafety Framework

A National Policy on Biotechnology/Biosafety

A regulatory system to address safety in the field of modern biotechnology (incl. Biosafety Act, Reg. )

An administrative system to handle requests for permits (lab work, field releases of LMOs & products)

A decision making system that includes Risk Assessment and Management of LMO releases

Mechanisms for public participation and information sharing

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Surveys/Information gathering (need new Law etc?)

National Stakeholders workshops

Nationwide Awareness Creation Workshops (general public, farmers, industrialists, students, parliamentarians, policy implementors, researchers, radio discussions etc)

Technical Consultations

Preparation of National Biosafety Framework Docs

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Regulation of Agric Biotechnology in Ghana Development of National Biosafety Framework

References (2003)

1. Survey Report on Programmes for Safe Use of Biotechnology/Biosafety and Existing Status of Biotechnology and LMOs in Ghana.

2. Survey Report on Existing Legislation and Legal Instruments Related to Biotechnology in Ghana.

3. Regional Mechanisms for Harmonization of Biosafety Activities – A Survey Report.

4. National Biosafety Framework for Ghana - Administrative guidelines

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5. National Biosafety Guidelines. Part l, ll & lll

Part I Introduction to Biosafety Guidelines

6. Part II Guidelines for Laboratory & Field Work

7. Part III Movement of Regulated Materials & Commercial Releases

8. Guidelines on Public Participation, Information Sharing and Access to Justice with Respect to GMOs.

9. National Biosafety Framework for Ghana

10. Biosafety Bill

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Regulation of Agric Biotechnology in Ghana Biosafety References (2003)

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Regulation of Agric Biotechnology in Ghana L.I. 1887

Legislative Instrument, LI 1887 was passed on 30 Nov 2007

Biosafety (Management of Biotechnology) Regulation

Permit contained and confined field trials

Does not cover commercial releases

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Biosafety Law 831

Biosafety Law 831 came into force on 31 Dec 2011

Provisions of Act 831

Section 40 (2) Until Regulations are made under …….the Biosafety (Management of Biotechnology) Regulations, 2007 (L.I. 1887) shall continue in force as if made under this Act.

L.I. 1887 Biosafety Regulations currently being revised to address all the provisions under Act 831.

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Biosafety Law 831

Scope, Objectives and Establishment (art. 1 – 5)

Administration (art. 6- 10 )

Handling of Requests for Approvals ( art. 11 - 23)

Reviews and Approvals (art. 24 - 26)

Technical Advisory Committee (art. 27 - 30)

Regulatory agencies (art. 31 -32)

Inspections (art. 33 – 34)

Finance (art. 35 – 39)

Miscellaneous (art. 40 – 44)

SCHEDULES (5)

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Biosafety Law

Scope

regulates all biotechnology activities including contained and confined use, releases into the environment and placement in the market, export, import and transit of GMOs.

Not applicable to GMOs that are pharmaceuticals for human use.

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Regulation Agric Biotechnology in Ghana

Biosafety Law 831

Objectives

(1) Ensure adequate level of protection in the field of safe development, transfer, handling and use of GMOs resulting from biotechnology that may have adverse effect on health and the environment.

(2) To establish a transparent and predictable process to review and make decisions on GMOs specified under the scope of the Act and related matters

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Establishment of the National Biosafety Authority

Functions

To receive, process, respond to and to make decisions on applications under and in conformity with this Act.

To establish administrative mechanisms to ensure the appropriate handling and storage of documents and data in connection with the processing of applications and any other matter covered by this Act

To promote public awareness, participation and education concerning the activities of the Authority.

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Governing Body

experts in biotechnology and related sciences incl. biosafety

Chairperson of TAC

One rep Ministry responsible for Science

One rep AGI

One legal practitioner

One rep NGOs

Two rep from Academia

One rep CSIR

One rep MOFA

One rep MoH

One rep Customs-GRA

Chief executive officer

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Handling of requests for approval -

Application for Contained or Confined use (art. 11)

Introduction into the environment (art. 12)

Import or place on the market (art. 13)

Export (art. 14 ) - Advance Informed Agreement

GMOs in Transit (art. 15)

Gazette publication (art 18) and also avail portions of application to persons on request

Risk assessment and Risk management (art. 19)

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Determination of the application (art.21)

information submitted by applicant

Risk assessment report

Relevant comments submitted by the public

Socio-economic considerations arising from impact of the proposed activity and the GMO on the environment. (Clear definition and application)

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Communication of decision (art. 22)

not later 180 days after receipt of complete application.

approval shall set out clearly the specific conditions related to the approval

approval shall be specific and limited to the activity authorized as set out in the decision document.

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Review of approvals

applicant or regulatory agency

Significant new scientific information that approved GMO or the approved activity may have adverse effect on human, plant, animal health or the environment

If the Appeals Board is satisfied that a change in decision is warranted a revised decision will be issued.

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Withholding information (art. 25)

Information obtained by applicant after approval

Which could change the evaluation of the risk posed by the intended activity

information not disclosed with the application

Attracts a fine (2,500 – 5,000 penalty units) or imprisonment (5 – 10 years) or both

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Appeals tribunal (art. 26)

A person aggrieved by

Refusal to grant approval

Conditions of the approval

Revocation, suspension or revision of an approval

Refusal to treat an application as confidential

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Technical Advisory Committee (art. 27)

Membership and tenure defined

CSIR rep, GAEC rep, socio-economists (2), ecologists / experts in GMO development and release (2)), Regulatory agents

act as the national advisory body on matters related to GMOs and

carry out risk assessment

audit applications at the request of Board

Submit proposals for regulations and guidelines

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Regulatory agencies (art. 31)

Monitor applicants activities for compliance

Customs Division-GRA

Food and Drugs Authority

Environmental Protection Agency

Plant Protection & Regulatory Services Directorate

Veterinary Services Directorate

District, Metropolitan, Municipal Assemblies and other local government authority.

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Inspections (art. 33)

Biosafety inspectors

Enter any premises, vessel or property, which the inspector has reason to believe it is necessary to enter, in order to ascertain compliance with provisions of this Act including approvals.

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Public awareness and participation (art.42)

NBA shall promote public awareness, participation and education concerning biosafety matters

publication of this Act and regulations in local languages

public lectures, seminars and workshops

Publish notices of final decisions in the Gazette as well as in electronic and print media.

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Civil liability and redress (art. 43)

Liability or redress for a damage that occurs as a result of an activity under this Act is subject to the applicable laws

eg· Pesticides Control & Management Act, 1996 (Act 528)

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Liability and redress and THE COMPACT (2010)

To provide a united framework for addressing potential claims, the leading agric biotech provider companies – BASF, Bayer CropScience, Dow AgroSciences, DuPont, Monsanto and Syngenta- agreed t establish a binding contract for international arbitration to offer United Nations Member States a legally binding mechanism for seeking redress from a responsible party if the release of an LMO by that party causes damage to biological diversity.

The COMPACT complements domestic and intnl laws incl. Supplementary Protocol on Liability and Redress

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Conclusions

Certified Institutional Biosafety Committees (IBCs)

Inspected and Certified Laboratories and containment facilities.

Constituted Technical Advisory Committees

Evaluated and Approved 3 Applications for Confined Field Trials (CFT).

• Nitrogen efficient, water efficient, salt tolerant Rice

• High protein Sweet Potato

• Insect (Maruca) resistant Cowpea

• Development of Regulations for Act 831 on going.

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MEDA HOM ASE

THANK YOU

Introduction

Biosafety: refers to the need (measures ) to protect human health and the environment from the possible adverse effects of the products of modern biotechnology

Risk Assessment: the term used to describe the science-based safety review carried out during research, development and production of transgenic crops to ensure safe use.

Risk = Hazard x Exposure

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Government & Nonprofit

B4FA 2013 Ghana: Agricultural biotechnology and the regulatory environment - Josephine Nketsia-Tabiri