Regulatory Status of Modern Biotechnology in SADC. Martha Kandawa-Schulz and Alex Owusu-Biney Harare, Zimbabwe

Transcription

1 Regulatory Status of Modern Biotechnology in SADC Martha Kandawa-Schulz and Alex Owusu-Biney Harare, Zimbabwe 1

2 Status of GMO Regulation in Southern Africa Region Promulgated Laws Approved NBFs with draft Legal Instruments No NBFs nor Laws Regional Model regulations/guidelines 2

3 Party Legislation Comments/Status Regulatory Status of Southern Africa Angola No Biosafety Law No NBF or law specific on Biosafety Botswana No Biosafety Law esults/?searchid= Democratic Republic of Congo Lesotho Madagascar No Biosafety Law, Principles for Environmental Protection Draft Biosafety Bill Draft instruments in development on Biosafety ecord.shtml?documentid= esults?searchid= Malawi Biosafety Act 2002 with Regulations attachment/?id=13824 Mauritius GMO Act lts/?searchid= Regulations/Guidelines developed Mozambique Biosafety Decree no 6/ record.shtml?documentid=

4 Status of Legislation in Southern Africa Party Legislation Comments/Status Namibia Biosafety Act 2006 (Act No 7) ttachedfile.aspx?id=1705 Seychelles South Africa No Biosafety Law, Environment Protection Act GMO Act (No.15) and Regulations 1997 Institutional capacity building on going with supportive regulation/guidelines ttachedfile.aspx?id= lts/?searchid= Swaziland Biosafety Act lts/?searchid= Biosafety Regulations/guidelines developed under UNEP-GEF project, other procedures need to be finalized Tanzania Zambia Zimbabwe Environment Management Act with Biosafety Regulation Biosafety Act 2007 and Regulations on Food & Feed National Biotechnology Authority Act of 2006 [Cap14:31] & guidelines Data not on BCH lts/?searchid= esults/?searchid=

5 Party Institutional Arrangements Regulatory Status of Southern Africa Angola Botswana Democratic Republic of Congo Interim arrangements under the Ministry responsible for Biosafety on a case by case basis Interim arrangements under the Department of Agriculture. Biosafety draft law not finalized Interim arrangements under the Ministry of Environment on a case by case basis Lesotho Interim Arrangements under the Department of Environment Office of Registrar and support structures yet to be set up Madagascar No institutional arrangements in place. Malawi Mauritius Mozambique Regulatory decisions vested in the Minister to be supported by a Regulatory Committee and inspectorate functions outlined, Biosafety fund to be established by law (field trials under taken) National Biosafety Committee in place, BS Office yet to be established, need to have law fully promulgated to empower designated officers Need to strengthen capacity to implement the obligations of the law 5

6 Status of Legislation in Southern Africa Party Institutional Arrangements Namibia Seychelles South Africa Swaziland Tanzania Zambia Zimbabwe Biosafety Registrar, Biosafety Council established, need to designate not only the Secretariat of Council but also empower all the designated officers to fully operationalise the law No operational provisions for regulation of Modern Biotechnology Biosafety Registrar Office in place, Executive Council, Scientific Advisory Committee and related regulatory functions are in place, operational system with hands on experience in the management of GMOs Biosafety Registrar in place, other operational functions yet to be established and empowered (Field trials to be initiated or already done?) Network of Centers of Excellence established to support the National Biosafety Focal Point, Ministerial Competent Authorities established, more capacity building needed to operationalise Biosafety functions Biosafety Registrar, National Biosafety Authority established, Scientific Advisory Committee and Inspectorate functions established by law, need to empower designated institutions to operationalise functions National Biotechnology Authority in place with CEO, and supportive institutions need further capacity to move from managing field trials to other 6 tasks highlighted in the lawid=535078

7 No NBFs or Known Draft Laws c. Angola Ref: All other parties in the sub region have at least a draft NBF and/or a draft law 7

8 National Biosafety Regulatory Frameworks Schematic Presentation Decision Making Body Minister/Governing Board/Agency Responsible for making decisions/issuing permits Govt Agencies, Civil Society, Private Sectr & Other Stakeholders Public Applicant Implementing Agency Inspectors, Regulations, Guidelines, Appeals (Use existing agencies, new agencies or external consultants Technical Advisory Committee(s) /Independent Panels/External Reviewers (Scientific Reviewers)

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10 Soft Laws/Voluntary Codes/Regulations AU Biosafety Model Law {23 articles and 5 annexes} Ongoing sub regional regulatory harmonisation processes through the RECs eg. COMESA, SADC 10

11 KEY NEW ELEMENTS ON THE REVISED MODEL LAW 1. PREAMBLE Recognizes that African countries need to deal with import of GMOs through aid or trade GM free zones AMCOST decision Executive Council resolution to take on common approach on matters pertaining to biotechnology and biosafety Guided by African Strategy on Biosafety

12 Regional Biosafety Regulations Common Market for Eastern and Southern Africa (COMESA) Draft Policy Statements and Guidelines for: i.commercial Planting of GMOs ii.trade in GMOs iii.emergency Food Aid with GMO Content 12

13 COMESA Draft Policy Statements and Guidelines GUIDANCE FOR SETTING THE FRAMEWORK GMO Entity Appropriate Option Reasons Advanced Commercial planting centralized regional assessment, national decision-making standardized and more transparent, cost effective sharing of resources, information and expertise Commercial trade policy Food aid policy advice/information from central regional clearing house, national decision Guidelines developed at regional level, decisions to be taken at the country level on a case by case basis regional level assessment is cost effective Cooperation in assessing issues Assures national commitment Information sharing Capacity building Facilitates transit of food aid in neighbouring states Facilitates provision of food 13 to the needy

14 COMESA Draft Policy Statements and Guidelines Started as a RABESA initiative and later supported by ACTESA Key elements ARTICLE 1.0 DEFINITIONS AND ACRONYMS ARTICLE 2.0 PREAMBLE ARTICLE 3.0 COMMERCIAL PLANTING OF GMOS ARTICLE 4.0 COMMERCIAL TRADE IN GMOs ARTICLE 5.0 HANDLING FOOD AID WITH GM CONTENT ARTICLE 6.0 CAPACITY BUILDING ARTICLE 7.0 COMESA BIOTECHNOLOGY AND BIOSAFETY INFORMATION DESK ARTICLE 8.0 MONITORING AND SURVEILLANCE ANNEX 1: GUIDANCE ON INFORMATION IN APPLICATION FORMS AND RISK ASSESSMENT AS PER CARTAGENA PROTOCOL ON BIOSAFETY (CPB) [ANNEXES I AND II AND III] 14

15 FLOWCHART OF THE PROCEDURES FOR CENTRALIZED RISKASSESSMENT 15

16 SADC Guidelines on GMOs, Biotechnology and Biosafety Southern African Development Cooperation (SADC) First REC to Develop Guidelines SADC Guidelines on GMOs, Biotechnology and Biosafety. The Guidelines focus on 4 general areas: (i) Handling of Food Aid; (ii) Policy and Regulations; (iii) Capacity Building; and (iv) Public Awareness and Participation 16

17 Potential Regulatory Harmonisation Issues EU membership versus AU/RECs non membership (Implications for harmonisation article 3j) Party obligation vs Regional Agreements guided by Protocols on goods and services Import of article 14 Regulatory issues which are transboundary with trade and environmental implications [data sharing through the BCH article 20) 17

18 FOCUS FOR SUPPORT Develop and adapt new and existing regulatory and enforcement tools to support decision making under the national biosafety regulatory frameworks 18

19 Potential Areas of Intervention Stocktaking analysis - Review and case studies of regulator and enforcement mechanisms from national biosafety systems Need for pilot studies/data Strengthening capacity for compliance and enforcement [toolkits, training workshops, checklists] 19

20 Potential Areas of Intervention [II] Developing networks for enforcement cooperation; and Raising awareness of the importance of environmental compliance and enforcement among relevant stakeholders. 20

21 Capacity Building issues identified Need for long-term training in LMO/GMO handling, inspection and monitoring for most parties Support wherever feasible, existing relevant personnel, such as agricultural inspectors or quarantine officers, environmental/food safety officers, to handle biosafety enforcement instead of training and deploying completely new staff. Need for necessary infrastructure and toolkits (e.g., laboratories for LMO/GMO testing and identification) to support monitoring and enforcement activities. 21

22 CONCLUSION Parties in SADC are at various stages of formulating policies, legislative and thematic frameworks for governing GMOs. They all are in agreement that regulation of GMOs is a party obligation. The thrust of transboundary movements may need a strong inter-party or regional cooperation. Owing to natural, economic and socio-technical disparities among countries, there is need for policy harmonization in developing and enforcing the various GM regulatory standards and frameworks. The need for policy harmonization on regulation of GMOs in Africa cannot be overstated given that ecological, ethnic, cultural and commercial considerations transcend the national boundaries of many countries. Except South Africa, Zimbabwe and Namibia, all the other countries in the region need to operationalise the institutional arrangements Zambia & Malawi have started the process of institionalising the provisions of the regulatory framework eg. National Biosafety Authority of Zambia

23 CONCLUSION cont d It is also prudent to acknowledge governments in desiring to preserve their right of handling GMO regulation by setting up appropriate regulatory systems and standards of their own before seeking ways to harmonize regulations on regional or continental scale. While there is agreement about the need for a GMO regulatory framework, there are differences in opinion about how strict it should be, as this is influenced by different issues (costs, perceived risks and benefits of GMO release, enforceability and credibility of the regulatory framework) In addition, the varied approaches available for GM regulations can also have far reaching implications on intercountry trade and distribution of food aid during emergency situations.

24 Sharing of ideas/comments/questions??? Thank You 24

25 Contacts for Further Information Alex Owusu-Biney Portfolio Manager (Biosafety), GEF Coordination Division of Environmental Policy Implementation UNEP P. O. Box Nairobi, Kenya Tel: Fax: /