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PUBLIC PARTICIPATION AND AWARENESS: NATIONAL BIOTECHNOLOGY REGULATIONS

PUBLIC PARTICIPATION AND AWARENESS: NATIONAL BIOTECHNOLOGY REGULATIONS. Vivencio R. Mamaril Vice-Chair, DA-BPI Biotechnology Core Team. SCOPE. 1. National Biotechnology Regulations a. Executive Order 430 of 1990 b. Department of Agriculture-

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PUBLIC PARTICIPATION AND AWARENESS: NATIONAL BIOTECHNOLOGY REGULATIONS

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  1. PUBLIC PARTICIPATION AND AWARENESS: NATIONAL BIOTECHNOLOGY REGULATIONS Vivencio R. Mamaril Vice-Chair, DA-BPI Biotechnology Core Team

  2. SCOPE 1. National Biotechnology Regulations a. Executive Order 430 of 1990 b. Department of Agriculture- Administrative Order No. 8 Series of 2002 2. Government Initiatives in Public Participation and Awareness

  3. I. NATIONAL REGULATIONS ON BIOTECHNOLOGY (1) • Executive Order No. 430 Constituting the National Committee on Biosafety of the Philippines (NCBP) and for Other Purposes • This UPLB-IRRI-DA proposal underwent several rounds of consultation with both the private and public sector under the auspices of the National Academy of Science and Technology. The resulting draft was then submitted to the Department of Science and Technology with a recommendation that the NCBP be established.

  4. I. NATIONAL REGULATIONS ON BIOTECHNOLOGY (2) Executive Order No. 430 • Upon the constitution of the NCBP, the draft biosafety guidelines were subjected to another round of scrutiny before approval. • Publish the result of internal deliberation and agency reviews of the committee; • Hold public deliberations on proposed national policies, guidelines and other biosafety issues;

  5. I. NATIONAL REGULATIONS ON BIOTECHNOLOGY (3) Executive Order No. 430 The Institutional Biosafety Committee (IBC). All Institutions engaged in genetic engineering and/or potentially hazardous biological and/or genetic engineering work are required to have an Institutional Biosafety Committee (IBC), which will evaluate and monitor the biosafety aspects of their biological research. Where an institution intends to become involved in planned field release research, members of the IBC should collectively have the range of expertise necessary to supervise and assess this.

  6. I. NATIONAL REGULATIONS ON BIOTECHNOLOGY (4) Executive Order No. 430 • Composition of IBC • Composed of five (5) members with expertise in genetic engineering or pest, or who have the capability to assess the safety of research. At least two (2) members shall not be affiliated with the institution and shall represent the interest of the surrounding community with respect to health and protection of the environment; • IBC may have consultants-on-call who are knowledgeable on the commitments and policies of the institution; applicable laws; standards of professional conduct and practice; community attitudes; and the environment.

  7. I. NATIONAL REGULATIONS ON BIOTECHNOLOGY (5) Executive Order No. 430 One of the functions of IBC is to hold discussions on the comparative ecological, economic and social impacts of alternative approaches to attain the purposes/objectives of the proposed genetic engineering products and/or services.

  8. I. NATIONAL REGULATIONS ON BIOTECHNOLOGY (6) Executive Order No. 430 • PLANNED RELEASE APPLICATION AND REVIEW • Public Notification and Comment -- IBC, shall take steps to notify the public of the planned release and to invite comments thereon. • Post for three consecutive weeks, the NCBP-approved Project Information Sheet for Purposes of Public Comment/Notification) in at least three (3) conspicuous places in the barangay(s) where the test site is located or which may be affected by the proposed release.  

  9. I. NATIONAL REGULATIONS ON BIOTECHNOLOGY (7) Executive Order No. 430 • Public Notification and Comment • Publish the Project Information Sheet once a week for at least two (2) consecutive weeks in a newspaper of general circulation in the areas where the test site is located or which may be affected by the planned release.   • If in the judgment of the IBC, the proposed planned release carries potentially significant risks to human health and the environment, the IBC shall conduct a public hearing not later than ten (10) days from the last day of publication.

  10. I. NATIONAL REGULATIONS ON BIOTECHNOLOGY (8) Executive Order No. 430 PROJECT INFORMATION SHEET FOR PURPOSES OF PUBLIC NOTIFICATION/COMMENT Name of Institution, Address of Institution, Name of Project Leader, Address/Telephone/Facsimile Numbers/e-mail address, Organism(s) to be Released, Purpose(s) of the Planned Release, Advantages/Disadvantages of the Proposed Strategy over Existing Methods, Brief Summary of the Nature and Effects of the Organism(s) to be Released, Location and Size of the Planned Release, Duration of the Project Involving Planned Release. Start/End, Government Agencies, Consulted Before Release, Additional information may be obtained from, the proponents or his organization, We invite the public to comment on, this planned release. Please address comments to: The Secretariat, National Committee on Biosafety of the Philippines 2nd Floor, Room 211, DOST Main Bldg.,Department of Science and Technology, Gen. Santos Ave., Bicutan, Taguig, Metro Manila, Telephone/Facsimile Nos. (632) 837-2930, (632) 837-2943, e-mail: jfle@dost.gov.ph

  11. I. NATIONAL REGULATIONS ON BIOTECHNOLOGY (9) B. DA-Administrative Order No. 8, S2002-Rules and Regulations for the Importation and Release into the Environment of Plants and Plant Products Derived from the Use of Modern Biotechnology

  12. I. NATIONAL REGULATIONS ON BIOTECHNOLOGY (10) DA-AO No. 8, S2002 “IBC” means the Institutional Biosafety Committee established by an applicant in preparation for the field testing of a regulated article and whose membership has been approved by BPI. The other members, who shall be designated as “community representatives”, shall not be affiliated with the applicant apart from being members of its IBC and shall be in a position to represent the interests of the communities where the field testing is to be conducted. For the avoidance of doubt, NCBP shall be responsible for approving the membership of the IBC for contained use of a regulated article.

  13. I. NATIONAL REGULATIONS ON BIOTECHNOLOGY (11) DA-AO No. 8, S2002 “Public Hearing” means the face-to-face meeting with relevant stakeholders to inform them of, and give them the opportunity to submit their comments on, any application for field testing of a regulated article which may pose significant risks to human health and the environment. “Public Consultation” means the process of informing relevant stakeholders of, and giving them the opportunity to submit their comments on, any application for field testing, propagation or importation for food or feed, or for processing, of a regulated article.

  14. I. NATIONAL REGULATIONS ON BIOTECHNOLOGY (12) DA-AO No. 8, S2002 FIELD TESTING OF REGULATED ARTICLES Public Consultation – The applicant, through its IBC, notifies and invites comments on the field testing proposal from the barangay and city/municipal governments with jurisdiction over the field test sites. The IBC posts for 3 consecutive weeks copies of the Public Information Sheet (PIS) for Field Testing approved by the BPI in at least 3 conspicuous places in each of the concerned barangay and city/municipal halls. The PIS for Field Testing invites interested parties to send their comments on the proposed field testing to BPI within a period of thirty 30 days from the date of posting. It is in a language understood in the community. During the comment period, any interested person may submit to BPI written comments regarding the application.

  15. I. NATIONAL REGULATIONS ON BIOTECHNOLOGY (13) DA-AO No. 8, S2002 PUBLIC INFORMATION SHEET FOR IMPORTATION FOR DIRESCT USE AS FOOD, FEED, OR FOR PROCESSING PROPOSAL FOR THE IMPORTATION Name of Applicant, Address/Telephone & Facsimile Nos./ E-Mail Address, Name of Responsible Officer/Authorized Representative, Description of the Regulated Article for propagation, Country(ies) of Origin of the Regulated Article, Purpose of the Importation, Brief Summary of Potential Effects on Human Health and the Environment,   The public is hereby invited to submit their comments on the proposed propagation, within thirty (30) days from the date of publication, to: THE DIRECTOR, Bureau of Plant Industry, Department of Agriculture, San Andres, Malate, Manila, Email address: bpinin@info.com.ph, Telephone no.: (02) 524-0768, (02) 525-7857, Fax no.: (02) 521-7650

  16. I. NATIONAL REGULATIONS ON BIOTECHNOLOGY (14) DA-AO No. 8, S2002 Biosafety Permit For Direct Use as Food or Feed, or for Processing “The permittee shall duly inform the public by way of publishing in any one (1) of the top three (3) leading newspapers in the country that import of this product is covered by conditions for approval as provided in Department of Agriculture Memorandum Circular No. 8, Series of 2003. A copy of such publication shall be submitted to the Bureau of Plant Industry within ten (10) days after publication.”

  17. I. NATIONAL REGULATIONS ON BIOTECHNOLOGY (15) DA-AO No. 8, S2002 Public Consultation. The applicant shall publish in 2 newspapers of general circulation a copy of the Public Information Sheet (PIS) for Propagation approved by BPI. The PIS for Propagation invites interested parties to send their comments on the proposed release for propagation to BPI within a period of 30 days from the date of publication. Any interested person may submit to BPI written comments regarding the application and these shall become part of the application file.

  18. I. NATIONAL REGULATIONS ON BIOTECHNOLOGY (16) DA-AO No. 8, S2002 PUBLIC INFORMATION SHEET FOR PROPAGATION  PROPOSAL FOR THE PROPAGATION OF Name of Applicant, Address/Telephone & Facsimile Nos./ E-Mail Address, Name of Responsible Officer/Authorized Representative, Description of the Regulated Article for propagation, If to be Imported, Country(ies) of Origin of the Regulated Article, Brief Summary of Potential Effects on Human Health and the Environment,   The public is hereby invited to submit their comments on the proposed propagation, within thirty (30) days from the date of publication, to: THE DIRECTOR, Bureau of Plant Industry, Department of Agriculture, San Andres, Malate, Manila, Email address: bpinin@info.com.ph, Telephone no.: (02) 524-0768, (02) 525-7857, Fax No.: (02) 521-7650

  19. DELISTING OF REGULATED ARTICLE Publication of the Petition. Within 5 days from receipt of the petition, the petitioner publish the petition in2 newspapers of general circulation with a notice soliciting comments thereon from the public. The notice invites interested parties to send their comments on the petition for delisting to BPI within a period of 60 days from the date of publication. During the comment period, any interested person may submit to BPI written comments regarding the petition and these shall become part of the petition file. I. NATIONAL REGULATIONS ON BIOTECHNOLOGY (17) DA-AO No. 8, S2002

  20. II. GOVERNMENT INITIATIVES IN PPA (1) • Scientist-Bishops Dialogue on Modern Biotechnology: • Royal Mandaya Hotel, Davao City • February 13, 2003 • A highly critical discussion on modern biotechnology which concerns the religious sector primarily the Catholic Church • Davao was the appropriate venue for the south since it represents the geographical center in Mindanao thus providing an opportune venue and representation for the regions in the south.

  21. II. GOVERNMENT INITIATIVES IN PPA (2) • Dialogue with the Church and Public Discussion on • Modern Biotechnology • Tuguegarao, Cagayan and Cagayan Valley • June 10, 2003 • DA Biotech Advisory Team gave a comprehensive presentation of the issues and have presented some enlightening insights • Productive discussion on the church related concerns of this new technology • Produced remarkable development on the stand of the church representatives in the forum on the issues in and around biotechnology including hunger and poverty

  22. II. GOVERNMENT INITIATIVES IN PPA (3) • Safety Application of Modern Biotechnology in Food and • Crops, 2nd National Agricultural Safety Convention, • Davao City • April 29, 2003 • The venue in the south was a good chance for the program to disseminate scientific information regarding the safety of biotechnology for food and crops production • Gathered a representative audience from the LGUs all over the country to convene on a very timely topic on agricultural safety where biosafety of biotech products is often being questioned.

  23. II. GOVERNMENT INITIATIVES IN PPA (4) • Keeping the food supply and farm environment safe: Regarding Bt Corn and other GMOs, Roxas City, Capiz • September 18, 2003 • Topics on biosafety of biotech products were the main feature of conferences • Presentation and discussions served as eye opener for the various audiences composed of farmers and farmer’s organizations, LGU representatives, and also representatives from the trade and industry sector, and NGOs • Provided scientific information in layman style and form that made them appreciate more the products of modern biotechnology including the efforts of the government to assure human and animal health and the environment safety

  24. II. GOVERNMENT INITIATIVES IN PPA (5) • “Writeshop @ Biotech.Com” • Biotech Media Workshop • March 21, 2003 • 1-day workshop for info campaign to set the tenor of the coming info activities for biotechnology • Participants include practicing media persons and information specialist form SEARCA-Biotechnology Information Center, the ISAAA, PhilRice, DZLB-UPLB, IPB-UPLB, CODA, and scientist and experts on modern biotechnology • Consensus highlighted the importance of utilizing positive information material for the general public using the conventional and popular media to be more effective and affective at the same time.

  25. II. GOVERNMENT INITIATIVES IN PPA (6) • GMO: Facts, Myths, Risks, and Benefits • Universidad de Sta. Isabel, Naga City • The venue tackled biotech issues that are popular for the general public particularly its safety correlated to facts and mythical risks.

  26. II. GOVERNMENT INITIATIVES IN PPA (7) • Seminar on AgBiotechnology: Benefits and Questions • Today, Potentials and Challenges Tomorrow • June 26, 2003 (Department of Agriculture) • June 27, 2003 (Imperial Suites) • Gathered together local scientists/experts and researchers on biotechnology for the comprehensive presentation of a visiting biotech expert from the Biotechnology Program of the University of California • Opened the discussion on the different biotechnology info campaign given much available and accessible information in the internet resources.

  27. II. GOVERNMENT INITIATIVES IN PPA (8) • Seminar on Feed Safety of GM Plants and Plant Products • Apacible Conference Room, DA • 21 August 2003 • Another US Biotechnology expert provided an update on current developments and most recent experiences in the US on the use of genetically modified plants and plant products for feeds • The US experience since 1996 is rich of lessons learned form actual account of using GM plants for feed use.

  28. II. GOVERNMENT INITIATIVES IN PPA (9) • “Scientist Speak Up” (Philippine Star, May 25, 2003) • National Newspaper Ad Released • A major public ad was released in the Philippine Star, as one of the competently corroborated info material by local scientist and experts on biotechnology to cap a hunger strike • The majority of the Filipino scientist from almost all research agencies and institutions of higher learning decided to be heard publicly through this major press release.  

  29. Thank You and Mabuhay!

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