1. ENVIRONMENT SAFETY: RISK ASSESSMENT AND MONITORING Clarito M. Barron, CESO IV Assistant Director, BPI and Chair, DA-BPI Biotechnology Core Team

2. 1.Regulatory Basis of Environment Safety 2.Environment Safety Risk Assessment 3.Insect Resistance Management for Bt Corn SCOPE OF PRESENTATION

3. DEPARTMENT OF AGRICULURE- ADMINISTRATIVE ORDER NO. 8 Series of 2002 (1) RULES AND REGULATIONS FOR THE IMPORTATION AND RELEASE INTO THE ENVIRONMENT OF PLANTS AND PLANT PRODUCTS DERIVED FROM THE USE OF MODERN BIOTECHNOLOGY

4. President GMA approved the Policy Statement on Modern Biotechnology, reiterating the government policy of promoting the safe and responsible use of modern biotechnology and its products as one of several means to achieve and sustain food security, equitable access to health services, sustainable and safe environment and industry development; DEPARTMENT OF AGRICULURE- ADMINISTRATIVE ORDER NO. 8 Series of 2002 (2)

5. Risk Assessment  Carried out in a scientifically sound and transparent manner based on available scientific and technical information  The identified characteristics of a regulated article and its use which have the potential to pose significant risks to human health and the environment shall be compared to those presented by the non-modified organism from which it is derived and its use under the same conditions  Risk assessment shall be carried out case-by- case and on the basis of transformation event. The required information may vary in nature and level of detail from case to case depending on the regulated article concerned, its intended use and the receiving environment

6. FIELD TESTING OF REGULATED ARTICLES (1)  Determine if the data obtained under contained conditions provide sufficient basis to authorize the field testing of the regulated article  Ensure that field testing does not pose any significant risks to human health and the environment  May require the proponent to perform additional experiments under contained conditions before acting on the field testing proposal Risk Assessment by Institutional Biosafety Committee (IBC)

7. The permittee shall comply with the following conditions:  The regulated article shall be maintained and disposed of in a manner as to prevent any significant risks to human health and the environment;  All packing materials, shipping containers, and any other materials accompanying the regulated article shall be treated or disposed of in such a manner as to prevent any significant risks to human health and the environment;  The regulated article shall be kept separate from other organisms, except as specifically allowed in the permit; FIELD TESTING OF REGULATED ARTICLES (2)

8.  The regulated article shall be subject to the application of remedial measures, including disposal, determined by the Director of BPI to be necessary to prevent any significant risks to human health and the environment ;  In the event new information becomes available indicating that the regulated article may pose significant risks to human health and the environment, the applicant shall on its own report to BPI and immediately take measures necessary to protect human health and the environment; FIELD TESTING OF REGULATED ARTICLES (3)

9. Revocation of Permit to Field Test  Receipt by BPI of new information that the field testing of the regulated article poses significant risks to human health and the environment;  Such other grounds as BPI may deem reasonable to prevent significant risks to human health and the environment. FIELD TESTING OF REGULATED ARTICLES (4)

10. PROPAGATION OF REGULATED ARTICLES (1) Permit Conditions:  The permittee shall submit to BPI monitoring reports on the performance characteristics of the regulated article in accordance with the monitoring reporting requirements specified in the permit;  The permittee shall notify the Director of BPI, verbally immediately upon discovery, or in writing within 24 hours, in the event that new information becomes available indicating that the regulated article can pose significant risks to human health and the environment;

11.  In writing as soon as possible, but not to exceed 3 working days, if the regulated article or associated host organism is found to have characteristics substantially different from those listed in the application, or suffers from any unusual occurrence (e.g., excessive mortality or morbidity, unanticipated effect on non-target organisms);  In the event new information becomes available indicating that the regulated article could pose significant risks to human health and the environment, the applicant shall on its own immediately take measures necessary to protect human health and the environment PROPAGATION OF REGULATED ARTICLES (2)

12. Revocation of Permit for Propagation  New technical information becomes available to BPI indicating that the propagation of the regulated article could pose significant risks to human health and the environment PROPAGATION OF REGULATED ARTICLES (3)

13. Executive Order 430 – Monitoring (1) (a)The IBC and appropriate government authorities shall monitor the planned release. The IBC shall submit to the NCBP the results of monitoring activities at intervals specified in the NCBP approval. (b)In accordance with agreements with line agencies, the DA shall be responsible for monitoring the movements and effects of GMOs or PHES approved for release; (c)The DENR shall be responsible for monitoring the environmental effects of the planned release

14. Plant Quarantine Service -Post Entry Quarantine Station implements the monitoring of GM contained experiments and field trials NCBP’s approval of a multi-location trial for Bt corn: Conditions  500m physical or temporal isolation of the GMO;  The proponent shall ensure that stray animals are excluded from the trial sites while tests are being conducted;  Harvested ears and kernels shall be heat killed and the vegetative plant parts shall be plowed under immediately after harvest;  The proponent shall include in its report, site- specific data on the agronomic characteristics normally taken in corn varietal adaptability trials. Executive Order 430 – Monitoring (2)

15. Monitoring activities for Bt corn trial: planting, soil sampling germination count, thinning, destruction of thinned out plants fist disease assessment second disease assessment third disease assessment harvest, data collection, soil collection, destruction of materials monitoring for volunteers Executive Order 430 – Monitoring (3)

16. ENVIRONMENT SAFETY: RISK ASSESSMENT (1) Host organism Donor organism Transformation system Inserted DNA Genetic stability Expressed material

17. THE HOST PLANT ENVIRONMENT Reproduction Biology Agricultural practices Pests and diseases CONSEQUENCES OF OUTCROSSING Out-crossing to related varieties Out-crossing to wild (or weedy) species ENVIRONMENT SAFETY: RISK ASSESSMENT (2)

18. WEEDINESS POTENTIAL Dissemination Seed dormancy Seed germination and or survival Time to maturity ENVIRONMENT SAFETY: RISK ASSESSMENT (3)

19. SECONDARY AND NON-TARGET EFFECTS Laboratory Studies -Novel protein, Sentinel species tested, Assay description, Biological significance and or other observations Field Studies Site information Arthropod species studied and or observed Sampling protocol Biological significance and or other observations ENVIRONMENT SAFETY: RISK ASSESSMENT (4)

20. INSECT RESISTANCE MANAGEMENT (IRM) FOR Bt CORN (1)  The permittee was required to submit an IRM for the approved transformation event  Special Order 2, S2004 –Technical Working Group for Pilot Testing of 80-20 Bag-in-bag IRM Strategy for Bt Corn- Evaluate proposed sites, recommend mechanisms to ensure effective and efficient implementation of the pilot testing, facilitate capability building activities and provide the necessary technical assistance in the pilot testing

21. Special Order 2, S2004 Planning and management committee- conceptualization and planning of IRM strategies Technical support committee – provide technical expertise in the implementation of IRM strategy Area coordinator- provide the Technical Working Group updates on the progress and development of the program INSECT RESISTANCE MANAGEMENT (IRM) FOR Bt CORN (2)

22.  Determine the acceptability and adoption of 80-20 bag-in-a-bag IRM strategy for Bt corn  Determine other factors that will enhance farmers cooperation in implementing the IRM strategy  To monitor pests, diseases and beneficial insects in a Bt and non-Bt cornfield in contiguous area INSECT RESISTANCE MANAGEMENT (IRM) FOR Bt CORN (3) Expected Outputs: Pilot Testing of 80-20 Bag-in- a-bag IRM Strategy for Bt Corn

23.  Data on the acceptance and adoption of farmers on the 80-20 bag-in-a-bag IRM strategy for Bt corn  Factors that affect farmers’ decision in complying with IRM strategy  Pests, diseases and beneficial insects profile in100 hectares area where 80-2 bag-in-a-bag packaging of Bt corn where seed was planted INSECT RESISTANCE MANAGEMENT (IRM) FOR Bt CORN (4)