RISK ASSESSMENT FOR PROPAGATION (FEED SAFETY)

1. RISK ASSESSMENT FOR PROPAGATION(FEED SAFETY) As presented by: ESTRELLA C. PANGANIBAN, DVM, PhD. Chief, Laboratory Services Division

2.  BAI Special Order no. 46, series of 2002 dated 17 May 2002 - Creation of a Task Force for the Regulation of Animal Feeds, Ingredients and Feed Products Derived from Biotechnology BAI Special Order No. 110, series of 2002 dated 6 November 2002 - Renaming and Reconstituting the Task Force for the Regulation of Animal Feeds, Ingredients and Feed Products Derived from Biotechnology into a Biotechnology Review Committee and Designating Officers & Providing Functions Thereof ISSUANCES

3. THE COMPOSITION OF THE BAI BIOTECHNOLOGY REVIEW COMMITTEE ARE AS FOLLOWS: • Chair of the committee • Co-chair of the committee • Sub-committee on host and donor organism and environmental safety • Sub-committee on toxicology and nutritional assessment • Sub-committee on molecular characterization, toxicity and allergenicity

4. FUNCTIONS OF THE BIOTECH REVIEW COMMITTEE • Review and evaluate protocols, dossiers and other related literature of GM crops and materials for the risk and safety assessment of animal feeds and feed products of GM origin intended for propagation and direct use as animal feed • Make appropriate recommendations or actions to the Bureau of Plant Industry (BPI) on submitted applications for GM crops • Attend and participate in trainings, seminars, workshops and consultative meetings to develop capabilities for the regulation of GM crops and materials • Address concerns and issue related to modern biotechnology as it affects the animal industry

5. ACTIVITIES PERSON GROUP RESPONSIBLE DETAILS Receives application of the technology developer Animal Feed Standardization Division (AFSD) - - The Bureau of Plant Industry provides the application - Refer to BPI BIOSAFETY PR 006 or BPI BIOSAFETY DR 0006 forms Sorts and labels reference documents according to sub-committee E. Estanislao of AFSD - - Sorting and labeling of reference documents according to Sub-Committees - Determining availability of members to meet for the Review sessions and giving notices of meeting (date should be within two weeks from receipt of application) STANDARD OPERATING PROCEDURE Feed Safety Assessment Of GMO

6. Hold review session of the application Needs Yes Additional Info Draft Feed Safety Risk Assessment Report Biotechnology Review Committee Chair and Co-chairs of Biotechnology Review Committee -     Brief orientation on the application by the chair and co-chair -         Review and evaluation of reference documents by sub-committees -   Presentation of reading outcomes of review by Subcommittees -  Includes discussion, critiquing and assessing of implications -     Inform BPI of the needed additional scientific documents, specifying topics of interest. - Arriving at a consensus regarding decision of application

7. Prepare final draft report Chair of Biotechnology Review Committee - The report is reviewed for accuracy - Solicitation of comments and other inputs by the members, re-drafting if necessary and others. Submit final feed safety risk assessment report to BPI Chair Biotechnology Review Committee -   - Preparation of the final report letter - Approval of the report letter by BAI Director - Submission of the report letter to BPI - Drafting of assessment report letter to the BPI Director on findings of the Committee

8. Comments/Observations (Risk Assessment of MON 810) • In General – The applicant should provide scientific documents explicitly stating documented findings specifically for MON 810.. References were sometimes made with MON 809 or other lines to infer that it is also true for MON 810 which may not always be the case. • On the inserted DNA- Information regarding the integrity and order of genetic elements within each insertion site (e.g., truncations, deletions rearrangements) could not be found for MON 810 in the provided documents. More mention was made with MON 809. • On Toxicological Assessment – Based on scientific findings, Bt corn was found to be degraded in a shorter time by both pre-heating and simulated gastric fluids. However, in simulated intestinal fluids, without pre-heating, degradation takes a much longer time. Concern is expressed on risks that might be posed to human health particularly on individuals who have had their stomach removed surgically due to health reasons (e.g. tumors, obesity). In this case, food goes directly into the intestines. Thorough pre-heating/processing is strongly recommended for such individuals when Bt corn is used for direct consumption

9. Comments/Observations (Risk Assessment of MON 810) • On Toxicological Assessment – Based on scientific findings, Bt corn was found to be degraded in a shorter time by both pre-heating and simulated gastric fluids. However, in simulated intestinal fluids, without pre-heating, degradation takes a much longer time. Concern is expressed on risks that might be posed to human health particularly on individuals who have had their stomach removed surgically due to health reasons (e.g. tumors, obesity). In this case, food goes directly into the intestines. Thorough pre-heating/processing is strongly recommended for such individuals when Bt corn is used for direct consumption • Since there is no pre-heating of animal feeds, we assume that the physical processing of the whole corn kernels into corn grits could suffice to hasten the degradation of the Bt corn in the animal. • On Nutritional Data – Submitted references for phytic acid were not enough to warrant a good assessment.

10. Comments/Observations (Risk Assessment of MON 810) • There are differences found on the resistance of the European Corn Borer (ECB) and Asian Corn Borer (ACB) to Bt Corn. It was mentioned that “tassel resistance has never been considered important for ECB” and that “tassel resistance is of outmost importance for ACB control in China”* it would be noteworthy to learn more about these findings. That is, on how we can relate this to the control and management of our ACB since we are also in the same region as China. • Cited from the work of He, Wang, Zhou, Wen, Song & Yao – Evaluation of Transgenic Bt Corn for Resistance to the Asian Corn Borer. From the Insect Resistance Management (IRM) Related Articles, page 9 of 20 pages (Monsanto, 2 of 2) On final note, we suggest that the BPI give the BAI and the other assessing agencies a short orientation on filling-up the Risk Assessment Report forms properly. We sometimes encounter different interpretations of the questions being asked due to format styles. We also need further explanations of some abbreviations (e.g., ORFs) and other unfamiliar terms.

11. EXPERIENCES AND LESSONS: Review and evaluation of documents • Do this at the same time with other members so that you can confer, confirm, clarify or validate with each another • To keep your mind focused, devote reading of documents to whole day sessions in a closed door venue with nothing else to do but this • Consider special physical arrangements so there is easy access to common documents and other documents are within reach

12. RECOMMENDATIONS • Need more familiarization courses on basic biotechnology • Request Agricultural Attaches for updates on GM crops/ to furnish the biotech core teams with information on: - Agricultural performance of GM Crops especially in Asian countries - Food and feed safety issues/concerns arising from these crops in a particular country - Banned or restricted GM crops or materials THANK YOU!