The Philippine Experience with Regulation and Risk Assessment of LMOs Merle B. Palacpac

1. The Philippine Experience with Regulation and Risk Assessment of LMOs Merle B. Palacpac Department of Agriculture Philippines

2. GMO Regulations in the Philippines • E.O. 430, s. 1990, created the National Committee on Biosafety of the Philippines • DA A.O. No. 8, s. of 2002, provided the guidelines for the importation and use (except contained use) of GM crops.

3. The National Committee on Biosafety of the Philippines • Inter-agency (DOH, DOST, DA, DENR) committee with 4 scientists and 2 community representatives • Is replicated at the institutional level through the Institutional Biosafety Committee • Issues Guidelines (for experimental use) • Conducts risk assessment with the Scientific and Technical Review Committee

4. Philippine Biosafety Guidelines Effectivity - 1981 • Guidelines on Planned Release of Genetically Modified Organisms (GMOs) and Potentially Harmful Exotic Species (PHES) • Effectivity – 9 September 1998 SCOPE • Applies to deliberate release (field testing) of GMOs and PHES into the Philippine environment (limited and multi-location testing of GMOs)

5. DA administrative order no.8 Importation and Release Into the Environment of Plants and Plant Products derived from the use of Modern Biotechnology Rules and Regulations

6. DA AO 8’s Essence is SAFETY • Safe and responsible use of modern biotechnology • DA has to address concerns on the risks of GMOs on human and animal health and the environment • The rules will further strengthen the existing regulatory system for the importation and the use of GMOs

7. What is Risk Assessment? • Scientific process of : • identifying potential adverse effects that might result from genetic modification by comparing the GM crops with its non-conventional counterpart • predicting the possibility that the identified potential adverse effect will occur • evaluating the identified risk

8. Risk Assessment Policy No person shall be allowed to import or release into the environment any regulated article without a satisfactory risk assessment conducted in accordance with the rules

9. Risk AssessmentPRINCIPLES • Carried out in scientific & transparent manner; based on available scientific & technical information • Lack of scientific knowledge or consensus not to be interpreted as indicating a particular level of risk, absence of risk, or acceptable risk

10. Risk AssessmentPRINCIPLES • To be carried out on a case-by-case basis • Identified characteristics of GMO and its use shall be compared to those of non-GMO from which it is derived and its use under the same conditions • If new information becomes available, risk assessment shall be readdressed

11. Responsible agencies for safety assessment and compliance: • Bureau of Plant Industry - lead agency and single entry point for applications and issuance of permits • Bureau of Agriculture and Fisheries Product Standards – for food safety assessment • Bureau of Animal Industry – for feed safety assessment • Fertilizer and Pesticide Authority - for the assessment of pest-protected plants

12. Technical support to BPI: • Scientific and Technical Review Panel (STRP), a non-DA pool of experts • Accredited laboratories • Outside experts

13. Different Areas of Safety Assessment for GM Plants and Plant Products 1. Contained use in greenhouse and laboratories 2. Field Testing 3. Release for Propagation 4. Direct use as food, feed, or processing

14. Sufficient in Form & Substance? • Submit: • 5 copies of Application Form • support documents (technical dossier; copy of PIS; & BPI certification that reg.art. has undergone satisfactory field testing in the Phils. Applicant 90 day period APPROVED BPI 60 day grace period to correct defects 5 day process/ evaluation period DENIED Evaluation and risk assessment STRP NO In all instances YES BAFPS 30 day period If pest-protected plant FPA If intended as feed APPLICATION TO RELEASE FOR PROPAGATION BAI For conduct of public consultation Applicant Shall publish PIS in 2 papers, & invite comments w/in 30-day pd.

15. Safety issues considered during risk assessment • Donor Organism • - description • - information on nutrient composition, known antinutrients, toxicants and allergenetic potential • - consumption patterns • 2. Host Organism • - description • - known toxicities and allergenicities • - the introduced gene

16. Safety issues . . . 3. Molecular characterization of the genetic modification - transformation system (Agrobacterium mediated, biolistic, etc) - Genetic stability of the introduced trait (multigenerational stability, segregation analysis) - the inserted DNA ( no. of insertion sites, integrity and order of the genetic elements within each insertion site, etc) - expressed material (amount and site where protein is expressed)

17. Safety issues. . . • Food/Feed Safety • Toxicological Assessment – evaluation of any toxins produced directly by the modification • Assessment of potential allergenicity • Assessment of changes in the concentration of nutrients or naturally occurring toxicants • Identification of anti-nutrient compounds altered

18. Safety issues . . . • Environmental Safety • Weediness potential- dissemination, seed dormancy, seed germination, time to maturity • Stability of the genetic modification • Susceptibility to pests and diseases • Consequences of out crossing – to related varieties or to wild species • Secondary and non-target adverse effects effects

19. The assessor summarizes the possible risks due to the LMO and recommends the mitigating measures or risk management strategies

20. Domestic Regulations vis-à-vis International Standards The Philippine GMO regulations are in compliance with the Cartagena Protocol on Biosafety and the Codex Commission Principles and Guideline. The regulations are continuously evaluated and modified to conform to internationally accepted standards and best practices.