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Hernani G Golez, Ph. D. Director

BPI’S ROLE IN BIOSAFETY REGULATIONS. RISK ASSESSMENT TRAINING-WORKSHOP May 24-28, 2004. Hernani G Golez, Ph. D. Director. Existing Biosafety Regulations (1). Executive Order No. 430 Issued on October 15, 1990 Instituting the National Committee on Biosafety of the Philippines (NCBP)

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Hernani G Golez, Ph. D. Director

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  1. BPI’S ROLE IN BIOSAFETY REGULATIONS RISK ASSESSMENT TRAINING-WORKSHOP May 24-28, 2004 Hernani G Golez, Ph. D. Director

  2. Existing Biosafety Regulations (1) • Executive Order No. 430 • Issued on October 15, 1990 Instituting the National Committee on Biosafety of the Philippines (NCBP) • Task of formulating national policies and guidelines on biosafety • BPI represents the Department of Agriculture in the institutional and individual composition of NCBP

  3. Existing Biosafety Regulations (2) • Department of Agriculture’s Administrative Order No. 8, Series of 2002 • Importation and Release into the Environment of Plants and Plant Products Derived from the Use of Modern Biotechnology

  4. Guiding Philosophies (1) We shall 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, a sustainable and safe environment, and industry development. Pres. Gloria M Arroyo July 16, 2001

  5. Guiding Philosophies (2) • Accelerate agricultural development, enhance production, and diversify products for food security and global competitiveness • Safe and responsible use of modern biotechnology could increase farm yield, improve quality of farm products, reduce use of pesticides and other inputs, enhance the environment, and reduce farmer/consumer exposure to pesticides

  6. COVERAGE: Regulated Article • Any plant which has been altered or produced through the use of modern biotechnology if donor organism, host organism, or vector or vector agent belongs to any of the genera or taxa classified by BPI as meeting the definition of plant pest or is a medium for the introduction of noxious weeds

  7. COVERAGE: Regulated Article • 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

  8. TYPES OF PERMIT • Permit to Import for Contained Use • Permit to Field Test • Permit for Propagation • Permit to Import for Direct Use as Food or Feed, or for Processing

  9. Laboratory Testing Field Testing Propagation/ Gen. Release/ Commercialization • Importation • Importation • Supervision • Importation • Monitoring Direct Use for Food, Feed or For Processing • Importation General Flowchart

  10. Submit: • 3 copies of Application Form; • NCBP Letter of Endorsement Applicant BPI Grace period of 60 days to correct defects Process & evaluate within 5 days of receipt Sufficient in Form & Substance? APPROVED YES Within 15 days from acceptance of application DENIED NO APPLICATION TO IMPORT FOR CONTAINED USE

  11. APPROVED Within 120 days from acceptance DENIED Shall submit report w/n 30 days Sufficient in Form & Substance? STRP For evaluation on risk assessment • Submit: • 3 copies of Application Form • support documents (technical dossier; copy of PIS; & NCBP certification that reg.art. has undergone satisfactory testing for contained use in the Phils. • If reg. art. is to be imported: • certification fr. country of import that reg.art. is of similar transformation event approved locally; • notification fr. country of import in accordance w/ existing international agreements on GMOs APPLICATION TO FIELD TEST Applicant Grace period of 60 days to correct defects BPI Process & evaluate within 5 days of receipt NCBP NO YES For consultation Shall post PIS for 3 consecutive wks, & invite comments w/in 30-day pd. Applicant thru IBC For conduct of public consultation Public Hearing by IBC (if STRP reports that release may pose significant risks

  12. 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. • If reg. art. is to be imported: • certification fr. country of import that reg.art. is of similar transformation event approved locally; • notification fr. country of import in accordance w/ existing international agreements on GMOs Applicant APPLICATION TO RELEASE FOR PROPAGATION Grace period of 60 days to correct defects APPROVED BPI Within 90 days from acceptance DENIED Process & evaluate within 5 days of receipt For evaluation on risk assessment STRP Shall submit report w/n 30 days In all instances BAFPS NO YES Shall submit report w/n 30 days If pest-protected plant FPA Shall submit report w/n 30 days 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.

  13. Grace period of 60 days to correct defects APPROVED Within 60 days of acceptance BPI DENIED STRP Process & evaluate within 5 days of receipt Sufficient in Form & Substance? Shall submit report w/n 30 days BAFPS Shall submit report w/n 30 days NO 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. • Submit: • 3 copies of Application Form • support documents (copy of PIS, & notification from country of import in accordance w/ existing international agreements on GMOs) Applicant For evaluation on risk assessment YES If intended as food If intended as feed APPLICATION FOR IMPORTATION FOR DIRECT USE

  14. PETITION FOR DELISTING • Submit: • 2 copies of Petition • published scientific literature relied upon Petitioner APPROVED Within 120 days from acceptance BPI ADD’L DATA REQUIRED Process & evaluate within 5 days of receipt DENIED For evaluation on risk assessment STRP Shall submit report w/n 30 days NO YES SatisfactoryRequirements? For publication of petition Petitioner Shall publish petition in 2 papers, & invite comments w/in 60-day pd.

  15. Advocacy • Capacity Building – risk assessment, risk communication, risk management, molecular biology, and molecular techniques • Public Consultations-biosafety policies and guidelines

  16. Maraming Salamat Po

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