Transcript Document
APPROVAL OF CORN MON 810 TRANSFORMATION EVENT: THE PHILIPPINE EXPERIENCE Clarito M. Barron Chair, BPI Biotechnology Core Team Bt corn- A Corn protected from corn borer damage, a GMO, which has bacterial gene transferred in the laboratory Non-Bt corn Bt corn Monsanto Philippines, Inc. Applicant Bureau of Plant Industry Regulatory Agency STRP, BAFPS, BAI, FPA Safety Risk Assessment-Food, Feed, and Environment Consistent Philippine Government Policy on BIOTECHNOLOGY (1979-date) • Corazon C. Aquino – EO 430-modern biotechnology regulation; R & D - NCBP, biotechnology high priority in Science and Technology • Fidel V. Ramos – first National Modern Biotechnology R & D Program in Agriculture signed AFMA into law – support for agricultural biotech • Joseph Ejercito Estrada – signed statement in support of agricultural biotechnology • Gloria Macapagal Arroyo – signed policy statement on modern biotechnology for national development; DA AO No. 8 S 2002 – regulation of plant and plant products produced through modern biotechnology DA AO No. 8 Series of 2002 Addresses risk of GM crops to • Human health • Animal health • Environment DA AO. No. 8 – regulates genetically modified plant and plant products • Central biosafety measure – science-based risk assessment, transparent, case by case, targettransformation event • Science-based risk assessment- Risk – chance of harm or injury, identification and evaluation of risk – based on scientific studies • Design of mitigating measures to reduce the risk – guided by information derived from scientific studies, if such information is lacking – regulators may require new study to obtain information before a decision is made POLICY ON RELEASE FOR PROPAGATION “No regulated article shall be released for propagation unless: (i) a Permit for Propagation has been secured from BPI; (ii) it can be shown that based on field testing conducted in the Philippines, the regulated article will not pose any significant risks to the environment; (iii) food and/or feed safety studies show that the regulated article will not pose any significant risks to human and animal health; and (iv) if the regulated article is a pestprotected plant, it’s transformation event has been duly registered with the FPA.” Submit: • 5 copies of Application Form Applicant Grace period of 60 days to correct defects If reg. art. is to be imported: • certification fr. country of import that reg.art. is of similar transformation event approved locally; • support documents (technical dossier; copy of PIS; & BPI certification that reg.art. has undergone satisfactory field testing in the Phils. • notification fr. country of import in accordance w/ existing international agreements on GMOs APPROVED Within 90 days from acceptance BPI DENIED Process & evaluate within 5 days of receipt For evaluation on risk assessment STRP Shall submit report w/n 30 days NO Sufficient in Form & Substance? YES In all instances BAFPS Shall submit report w/n 30 days If pest-protected plant FPA Shall submit report w/n 30 days APPLICATION TO RELEASE FOR PROPAGATION If intended as feed BAI Shall submit report w/n 30 days For conduct of public consultation Applicant Shall publish PIS in 2 papers, & invite comments w/in 30-day pd. Risk assessment of Bt corn The applicant was required to submit 1. Certification from NCBP that Bt corn MON810 field trials had been conducted and no unnecessary risk to the researcher or environment has been identified 2. Scientific reports to substantiate claim a. that Bt corn MON810 is safe and as nutritious as any ordinary corn variety whether for humans or animals b. that Bt corn MON810 does not pose risk to the environment more than the ordinary corn Food/Feed safety assessment (1) • Toxicity – level of native toxicants if present must fall within the range known for varieties of the species used as food, native toxicant if present, reacts to processing conditions similarly to native toxicants in non-GM varieties. No natural toxicant in corn • Nutritional value – nutrients levels within range known of varieties used as food, can substitute non-GM counterpart in food/feed preparation Food/Feed safety assessment (2) • Allergenicity – level of native allergens if any must fall within the range known for varieties of the species used as food, native allergens if any, reacts to processing conditions similarly to native toxicants in non-GM varieties. No natural allergen in corn Food/Feed safety assessment of Bt corn • Presence of Bt protein – only difference between Bt corn and non-Bt corn • Bt protein – assessed for possible toxicity and possible allergenicity • Bt corn – nutritional profile compared with ordinary corn Environmental safety issues in evaluating GM crop for commercial planting How does Bt corn compare with ordinary corn in the following? • Gene Flow • Gene transfer to related plants • Gene transfer to unrelated species Weediness potential Secondary and non-target effects - effect on nontarget organisms and other unintended effects Agronomic issues 1. Is Bt corn MON810 effective in controlling Asiatic corn borer, the advantage can be seen as increase in yield over borer- damaged non-Bt corn? 2. Is the Bt gene inherited like any ordinary corn gene? Evaluation of Scientific Reports To prevent pressure from anybody, evaluators were not publicly known during evaluation process and were not personally known to BPI Director 2 sets of independent evaluators a. DA regulatory agencies b. STRP – Scientific Technical Review Panel and non-DA scientists TECHNICAL EVALUATORS A. DA regulatory agencies 1. BAI – feed safety 2. BAFPS – food safety 3. FPA – safety of Bt protein in food and feed safety in handling Bt corn 4. BPI - environmental safety B. STRP – assess scientific quality of reports assess feed safety, food safety and environmental safety of Bt corn 3 former professors of UP Dr. Emiliana N. Bernardo – former ViceChancellor for Academic Affairs, UPLB Dr. Filipinas F. Natividad – Director, Biotechnology Research Division, St. Luke’s Medical Center, also former Director, Institute of Biology, UP Diliman Dr. Teodoro Abilay – former Director, BAI Basis of Approval by BPI Director Final conclusion by experts: 1. Bt corn MON810 is safe to humans, animals, non-target organisms & as nutritious as ordinary corn 2. Bt corn MON810 is safer than chemical insecticides 3. Bt corn MON810 is very effective in controlling Asiatic corn borer 4. The Bt gene is inherited like any ordinary corn gene RESULTS OF SAFETY RISK ASSESSMENT Human Health Animal Health Environment Remarks (Result of Evaluation) - Safe - For Approval BAFPS Safe - - For Approval FPA Safe Safe Safe For Approval BPI - - Safe For Approval STRP 1 - Safe Safe For Approval STRP 2 Safe Safe Safe For Approval STRP 3 Safe Safe Safe For Approval AGENCY / STRP BAI Permit to plant Bt corn – 5 years Monitoring Compliance to IRM strategy Development of resistant insects Other unintended effects Continuing submission of data to BPI Thank you for your kind attention