GRP ADOPTS CONFLICTED BIOSAFETY FRAMEWORK

UNCLAS SECTION 01 OF 03 MANILA 001862 SIPDIS SIPDIS SENSITIVE STATE FOR EB/TPP/ABT FOR SPIRNAK AND GOETHERT STATE PASS USDA/FAS/ITP FOR SIMMONS, RICHEY AND CLARKSON ICD FOR PETLOCK STATE PASS USTR FOR BWEISEL, MSANDLER AND DKATZ STATE PASS USAID FOR JLEWIS STATE PASS USDOC FOR 4430/ITA/MAC/KBOYD E.O. 12958: N/A TAGS: EAGR ETRD ECON SENV TBIO TSPL RP SUBJECT: GRP ADOPTS CONFLICTED BIOSAFETY FRAMEWORK REF: 05 Manila 12 SENSITIVE BUT UNCLASSIFIED, NOT FOR INTERNET, PROTECT ACCORDINGLY ¶1. (SBU) Summary. President Arroyo issued an executive order (EO) adopting the National Biosafety Framework (NBF) as a compliance mechanism under the Cartagena Protocol on Biosafety (CPB). The NBF, a compromise between pro- and anti-biotech policy makers, promulgates conflicting principles in recognizing the need for science-based risk assessments while allowing social, cultural, and ethical considerations to guide biosafety decisions. Adding non-science based requirements could make the existing regulatory system more restrictive, complicated, and detrimental to GRP Department of Agriculture and donor efforts to use biotechnology to promote agricultural productivity and food security. Without a funding mechanism, however, implementation of the EO will likely stall. End Summary -------------- National Biosafety Framework Adopted -------------- ¶2. (U) President Gloria Arroyo recently signed EO 514, establishing the National Biosafety Framework (NBF), prescribing guidelines for its implementation, and strengthening the National Committee on Biosafety of the Philippines (NCBP). The GRP approved the new framework despite DA, industry, and Post advocacy to use solely science-based assessments and move out socio-economic considerations from the coverage of the NBF (reftel). As a compromise, the drafters of the EO regarded non-science based assessments as discretionary provisions (versus mandatory as found in earlier versions of the NBF) that agencies may choose to require from technology developers. The EO also clarified that the 2002 DA Administrative Order No. 8 or the commercialization guidelines shall continue to be in force and applied in the evaluation and monitoring of plant and plant products derived from modern biotechnology, assuaging industry fears that the EO would disrupt the existing regulatory system. ¶3. (U) The NCBP, a multi-sectoral committee chaired by the Department of Science and Technology (DOST),was �A;tasked to oversee implementation of the NBF and set scientific, technical, and procedural standards on biosafety. The committee is composed of the secretaries of the Departments of Agriculture, Health (DOH), Environment and Natural Resources (DENR),Foreign Affairs (DFA),Trade and Industry (DTI),and Interior and Local Government (DILG); biological, physical, environmental, health, and social scientists; and representatives from consumer, community (such as farmer, fishermen, or indigenous people),and industry groups. ¶4. (U) The NBF is the Philippines' compliance mechanism to the Cartagena Protocol on Biosafety (CPB). Framers of the NBF contend that the framework will strengthen current science-based determination of biosafety and enhance decision-making by incorporating social, economic, ethical and cultural assessments. -------------- New Administrative Set-up -------------- ¶5. (U) NCBP reorganization to include DTI, DFA, DILG, and appoint representatives from consumers and industry could be completed in early 2008. In the meantime, NCBP- member agencies will continue to perform their regulatory functions, as follows: -- DOST will ensure that best available science is utilized in adopting biosafety policies, measures and guidelines and will take the lead in evaluating and monitoring biotech articles intended for use in laboratories and greenhouses. -- DA will address biosafety issues in promoting agricultural productivity and food security and will take MANILA 00001862 002 OF 003 the lead in evaluating and monitoring plants and plant products derived from biotechnology. -- DENR will ensure that environmental impact assessments are considered in biosafety decisions and will take the lead in evaluating and monitoring biotech articles intended for bioremediation and genetic and wildlife resources improvement. -- DOH will formulate health assessment guidelines and will take the lead in evaluating and monitoring processed food derived from or containing biotech products. ¶6. (U) As required under Article 19 of the CPB, DFA is the focal point for liaising with the Protocol's Secretariat. The above-mentioned agencies were also SIPDIS designated as competent national authorities for performing administrative functions under the Protocol. The NCBP Secretariat was designated the focal point for the Biosafety Clearinghouse, in compliance with Article 20 of the CPB. It will coordinate with the Protected Areas and Wildlife Bureau (PAWB),an attached agency to the DENR and the focal point for the Clearinghouse Mechanism under the Convention on Biological Diversity. -------------- -------------- Conflict Between Social and Scientific Principles -------------- -------------- ¶7. (U) The EO recognized several widely accepted guides to biosafety decision-making. It prescribed that risk assessments must be science-based and carried out on a case-by-case basis or applied to a "transformation event." In addition, consistent with WTO Sanitary and Phytosanitary harmonization rules, the EO reasserted the importance of expert advice from international bodies and regulatory authorities of countries with experience in biotechnology. The EO also subscribed to a more flexible "precautionary" approach in Articles 10 and 11 of the CPB that the lack of scientific knowledge or consensus does not indicate a particular level of acceptable risk. ¶8. (SBU) On the other hand, the EO adopted several other principles that directly conflict with science- based standards. For example, the EO drew from Article 28 of the CBP in permitting social, economic, ethical, and cultural assessments prior to commercialization. The EO also gave flexibility for GRP agencies to jointly issue environmental impact assessment guidelines as a requirement for biosafety decision-making. These additional requirements may be inconsistent with WTO principles and would likely lengthen the approval process and make the regulatory system tedious and prone to corruption. It could also make it more expensive for the private sector and public institutions -- which rely on meager national government budgets -- to commercialize their biotech innovations. -------------- Industry Reactions -------------- ¶9. (SBU) Monsanto, an American company, is concerned that as a result of the EO, biotech commercialization rules may become more restrictive and arbitrary. The company anticipates difficulty renewing its permit to commercially propagate Bt corn (MON810, the first biotech food crop approved for commercial release in Asia),which will expire in 2007. They are particularly worried about the DENR's environmental impact assessment system, which they perceive as prone to corruption. Biotech Coalition of the Philippines President Ben Pecson was surprised that the President signed the EO after it had languished in her office for nearly two years. He said the EO is inconsistent with the national policy to promote the use of biotechnology to address economic development goals. -------------- Another Unfunded Mandate -------------- ¶10. (SBU) The reorganization of the NCBP will commence MANILA 00001862 003 OF 003 only after an inter-agency group concludes an agreement to share financial and technical resources. Without its own funds, the NCBP would have to rely on ad hoc allocations from member agencies or external funding to implement the NBF and embark on capacity building programs identified in the EO. The DENR-PAWB is requesting additional funding from the United Nations Environmental Program's Global Environment Facility (UNEP- GEF) to implement the EO, just as it did a $175,000 grant in 2003 to develop the NBF. PAWB officials said the signing of the EO is an important milestone in securing additional funding for capacity building. Another is ratification of the CPB by the Senate, which started hearings and will likely ratify before the end of the year. -------------- Comment -------------- ¶11. (SBU) DENR and anti-biotech NGOs succeeded in securing the legal basis for adding non-science based assessments in the biosafety regulatory system. Although the NBF is toned down from earlier versions, it could complicate the biotech regulatory system and delay approvals for the use of GM products. Under the new rules, the biosafety assessment process -- from greenhouse to single site to multi-site to commercial release -- could take at least two years to complete. Approvals could take much longer if required to address non-science based considerations. The adoption of the EU- like provisions could undermine the Philippines' leadership role in agricultural biotechnology in Asia. Post will continue to monitor developments and work with the GRP and industry partners in assessing the EO's impacts on the biotech policy environment. KENNEY