Low Level Presence of Recombinant-DNA Plant Material: International Guidance and the Philippine Experience

Transcription

1 2008/SOM1/HLPDAB/005 Agenda Item: 1 Low Level Presence of Recombinant-DNA Plant Material: International Guidance and the Philippine Experience Purpose: Information Submitted by: University of the Philippines, Diliman High Level Policy Dialogue on Agriculture Biotechnology Lima, Peru February 2008

2 Low Level Presence of Recombinant-DNA Plant Material: International Guidance and the Philippine Experience Ernelea P. Cao, Ph.D. Professor, Institute of Biology and Director, Natural Sciences Research Institute University of the Philippines Diliman, Quezon City, Philippines The advances in the field of modern biotechnology has allowed for the development of genetically modified crops with improved qualities aimed at enhancing production and diversifying products for food security and global competitiveness. 1

3 Due to implications in trade, there is a need for an international regulatory framework for modern biotechnology. The Case of Low Level Presence of Recombinant-DNA Plant Material originally referred to as adventitious presence (AP) variously defined in different countries as unauthorized, unintended, disapproved, or unauthorized through contamination technically known as low level presence 2

4 Why is Low Level Presence a concern? Increasing number of approvals globally Differences in the timing and duration of governmental regulatory safety assessments ( asynchronous approvals ) Pollen drift during crop production Use of high-volume receiving, storage and handling systems that optimize quality and minimize costs to consumers Transportation conveyances Issue that will affect regulation and trade: How low is low level presence? Different countries will have their own definitions of low. Different countries may impose different policies on low level presence. Many countries implement a zero tolerance policy on unapproved events. 3

5 The Philippine Experience: For international guidance, uses the Codex Guidelines for the Conduct of Food Safety Assessment of Foods Derived from Recombinant-DNA Plants (CAC/GL ) for Risk Assessment Applications. For national guidance, has implemented through the Department of Agriculture, Republic Act 8435 of 1997 referred to as the Agriculture and Fisheries Modernization Act (AFMA), which aims to modernize the agriculture sector by transforming it from a resource-based to technology-based sector. Specific provisions for a biotechnology program are provided for in the act. In 2001, Philippine President Gloria Macapagal Arroyo declared a national biotechnology policy, that is promote the safe and responsible use of modern biotechnology and its products as one of the means to achieve food security, equal access to health services, sustainable and safe environment and industry development. With the above policy statement on modern biotechnology, coupled with the objective of the Department of Agriculture to accelerate agricultural development, enhance production, and diversify products for food security and global competitiveness, the need for a legal and strong framework on the importation and use of GMOs was emphasized. 4

6 Department of Agriculture - Administrative Order No. 8 (DA AO 8 series of 2002 entitled Rules and Regulations on the Importation and Release into the Environment of Plants and Plant Materials Derived from the Use of Modern Biotechnology ) covers the importation or release into the environment of any plant or plant product altered or produced through the use of modern biotechnology which may pose significant risks to human health and the environment based on available scientific and technical information. Under AO 8, no person shall be allowed to import or release into the environment any regulated article without a satisfactory risk assessment. The assessment of GM crops shall be: Science-based identification and evaluation of risk based on scientific studies Transparent basis for decision is open for public scrutiny Case by case different GMOs pose different types and levels of risk and should be assessed accordingly By transformation event - unit of analysis in evaluating GMOs 5

7 The Bureau of Plant Industry of the Department of Agriculture is the central agency overseeing the application and approval process. After processing and evaluating the documents submitted, the BPI farms out the papers to the different concerned agencies involved in the risk assessment process. Grace period of 60 days to correct defects Process & Evaluate within 5 days of receipt APPLICANT BPI Submit: 5 Copies of Application Form support documents (technical dossier; copy of PIS; and BPI certification that the regulated article has undergone satisfactory field testing in the Philippines Within 90 days from acceptance For evaluation on risk assessment If regulated article is to be imported: Certification from country of import that regulated article is of similar transformation event approved locally; Notification from country of import in accordance with existing international agreements on GMOs APPROVED DENIED STRP Shall submit report within 30 days In all instances BAFPS Shall submit report within 30 days NO Sufficient in Form & Substance? YES If pest-protected plant FPA Shall submit report within 30 days If intended as feed BAI Shall submit report within 30 days Applicant Shall publish PIS in 2 papers, & invite comments within 30 day period Flowchart of the Procedure for Application for Propagation 6

8 Scientific and Technical Review Panel (STRP) assess scientific quality of reports; assess feed safety and environmental safety DA Regulatory Agencies: Bureau of Agriculture and Fisheries Product Standards assess food safety Fertilizer and Pesticide Authority safety of pest-protected plants Bureau of Animal Industry assess feed safety Bureau of Plant Industry - environmental safety Science-based evaluation procedure Assessment Independently evaluated for safety by scientists or experts in nutrition, molecular biology, toxicology, allergenicity and other aspects of food science (at least 3 per event). 7

9 Challenges Scientific (especially for developing countries): Lack of adequately trained personnel Poor or limited access to up-to-date information on new concepts and techniques Inadequate funding for laboratories Regulatory: Setting-up of concrete national policies on low level presence partial or full risk assessment? Definition of low level presence the need to quantify? 8