QUESTION 15<br />The Philippines has a National Biosafety Framework as per Executive Order 514 (E.O. 514) issued on 17 March 2006. Guidelines are in place for risk assessment of agricultural plants and plant products by way of a Department of Agriculture Administrative Order No. 08, series of 2002. The Department of Environment and Natural Resource is formulating regulations for GM forest and wildlife resources. Guidelines are also in place for Contained Use of LMOs, including Transgenic Arthropods, which is being implemented by the Department of Science and Technology.<br />QUESTION 16<br />National Biosafety Framework- E.O. 514, issued on 17 March 2006 Regulations: DA AO No 8s. 2002 is based on Presidential Decree 1433, known as the Plant Quarantine Act, The Consumer Code, our commitments to WTO-SPS (World Trade Organization-Sanitary and Phytosanitary Measures), Adoption of Codex and IPPC (International Plant Protection Convention) standards. Biosafety Guidelines - Executive Order 430, issued on 16 October 1991, creating the National Committee on Biosafety of the Philippines; Philippine Biosafety Guidelines series of 1991; Guidelines on the Planned Release of GMOs and PHES (Potentially Harmful Exotic Species) issued on 8 September 1998; DA Administrative Order No. 8: Guidelines on Risk Assessment for Field Trials, Propagation and Direct Use for food, feed or processing, The Philippines Revised Guidelines on Contained use of GMOs (2014); The Philippines Guidelines on Containment of Transgenic Arthropods (2014). Other laws, regulations that indirectly apply to GMOs : Wildlife Resources Conservation and Protection, Plant Variety Protection Act, Network of Integrated Protected Areas, etc.<br />QUESTION 17<br />EO 514 mandates the DOST, DENR, DA and DOH to allocate from their existing budgets such amount as may be necessary to implement the NBF, including to support the operations of the NCBP and its secretariat. <br />QUESTIONS 18 and 19<br />Permanent staff per concerned agency and on top of their regular workload

As UN Member State the Philippines implements the World Health Organization Certification Scheme on the Quality of Pharmaceutical Products Moving In International Commerce (World Health Assembly Resolutions WHA22.50 (1969), WHA28.65 (1975), WHA41.18 (1988), WHA45.29 (1992) and WHA50.3 (1997).

QUESTION 25<br />The Philippines adopts the International Standards for Phytosanitary Measures No. 20 of the IPPC (Guidelines for a phytosanitary Import Regulation) to regulate the transit of LMOS. Although, the Department of Agriculture (DA) has no specific regulation for transit of GM agricultural crops/seeds at the moment, the Plant Quarantine Service (PQS) of the DA requires that if a shipment/container, a part of which is destined for the Philippines, is opened, PQS inspects the remaining part of the shipment. Otherwise, if shipments just pass the Philippines and are not opened or unloaded in the port, no inspection is done by PQS. So far, most shipments of GMOs destined to the Philippines are required to be in the Registry of Approved regulated articles and required to be accompanied by a Phytosanitary Certificate.<br />QUESTION 26<br />The Philippines have its own domestic regulation for contained use of GMOs: The Philippine Biosafety Guidelines, s. 1990; The Philippines Guidelines for Contained Use of GMOs (revised edition) September 2014

QUESTION&nbsp; 30<br />The Bureau of Plant Industry (BPI) requires a biosafety permit for LMOs for field test and propagation. The Biosafety permit for field testing is valid for 2 years while permit for propagation is valid for 5 years. The Plant Quarantine Clearance (Import Permit) which is a Sanitary and Phytosanitary (SPS) measure serves as the AIA.The Plant Quarantine Clearance (PQC) for GM seeds and commodities is based on the Approval Registry of Regulated Articles. In addition, it is required by the BPI that for every importation, a declaration of GM content should accompany the shipment upon arrival in the Philippines. <br />QUESTION 31<br />For LMOs introduced into the environment not subject to transboundary movement, a biosafety permit is required. The technology developer should apply for a biosafety permit from the BPI. Movement of LMOs within the country will require a domestic permit.<br />QUESTION 32<br />In general, all legal requirements are based on the WTO-SPS agreement. That is, if the country of import requires an SPS measure such as notification, the BPI issues a Plant Quarantine Certificate or certificate of GM content, whichever is required. Most importing countries requires a PQC consistent with Article 8 of the Cartagena Protocol on Biosafety. The Philippines can formally put in place in the future a legal requirement for exporters to notify in writing the Competent National Authority of the party of import prior to the intentional transboundary movement, including accuracy of information, as it deems necessary.<br />QUESTION 44<br />During the reporting period, the Philippines has a total of 15 approved importations, four of which is for field trial and 11 for propagation. There has been no cases of prohibiting imports.

UESTION 47<br />The DA has adopted specific regulations for decision making regarding domestic use, including placing in the market of LMOs for direct use as food and feed or for processing. Policy on importation and its approval process is stipulated under DA AO No. 8, s. 2002. <br />QUESTION 48<br />The DA has established legal requirements, as per DA AO No. 8, s. 2002, for the accuracy of information to be provided by the applicant.

The Department of Agriculture has established a mechanism for the review and change of a decision regarding an intentional transboundary movement of LMOs DA AO No.8, Section 3, Principles of Risk Assessment: "If new information on the regulated article and its effects on human health and the environment becomes available, the risk assessment shall be readdressed to determine whether the risk has changed or whether there is a need to amend the risk management strategies accordingly." DA AO No.8 likewise provides the conditions for a revocation of a permit. A permit is revoked if new technical information indicates that the regulated article will result in significant risk to human health and the environment The DA had already received a request for review of a decision

The Philippines has a regulatory framework in place.

GM development in the Philippines involves several stages, from contained use/confined test, field test and commercialization. <br />Risk assessment is conducted in all decisions taken for intentional transboundary movement of LMOs, be it domestic, propagation or FFP. <br />The Philippines' regulation provides that no regulated article shall be allowed to be imported or released into the environment without the conduct of a risk assessment performed in accordance with the rules. The risk assessment shall always be based on scientific evidence to identify and evaluate potential adverse effect, and in a manner that is transparent and on a case-by-case basis. Absence of information does not necessarily indicate/determine a certain level of risk, or absence of risk.<br />The Philippines use as risk assessment guidance the following: Codex Alimentarius Guidelines for the conduct of food safety assessment of foods derived from recombinant-DNA plants CAC/GL 45-2003; Cartagena Protocol on Biosafety; Recommendations of the Panel of Experts, Organisation for Economic Cooperation and Development (OECD), Executive Order No. 514 s. 2006, section 5.2.1 Principles of Risk Assessment.

The Philippines' regulation provides that all importations, particularly seeds, grains and those for processing should be accompanied by a GMO declaration, specifying the events/traits present in the consignment. Random sampling and testing in the laboratory are also conducted to check if the event(s) present are listed in the BPI Approval Registry.

The National Committee on Biosafety of the Philippines (NCBP) was established in 1990 to handle regulatory concerns on activities involving modern biotechnology. In 2006, Executive Order No. 514 was issued to delineate the mandates and functions of the four Competent National Authorities (CNAs): Department of Agriculture, Department of Environment and Natural Resources, Department of Health, and Department of Science and Technology. EO 514 also strengthened the NCBP to be the lead coordinating body of the efforts of all the government agencies involved in biosafety regulation.

The Philippines has made available in the Biosafety Clearing-House existing national laws, regulations and guidelines for LMOs intended for domestic use as food, feed, and processing. Contact details of the CNAs, national focal points and emergency contacts are likewise available in the BCH. Other information available include: reports on the operation of the Protocol; final decisions on importation and release of LMOs; domestic use of LMOs that may be subject to transboundary movement and taken under domestic regulatory framework; declarations regarding the framework to be used for LMOs intended for direct use as FFP; reviews and change on decisions on intentional transboundary movement of LMOs; and risk assessment.

EO 514 stipulates that concerned departments and agenices shall ensure that it has procedures and regulations to determine and protect confidential information on all applications for approvals, whether domestic or foreign. However, the concerned agencies may refuse declaring the confidentiality of such information if it is necessary to enable the concerned stakeholders to effectively conduct a scientific risk assessment. <br />On the other hand, DA AO No. 8 identifies the following information as non-confidential in the process of applying for a biosafety permit under the BPI:<br />Name and address of the applicant, Description of the regulated article, Description of the intended destination (including all intermediate and final destinations), Uses and distribution of the regulated article, Summary of risk assessment of the effects of the regulated article on the environment and human health, Where appropriate, description of the proposed procedures, processes and safeguards which will be used by the applicant to prevent escape and dissemination of the regulated article at each of the intended destinations,&nbsp; Description of the methods and plans for emergency response in case of accidental release of the regulated article into the environment; and Description of the proposed method of final disposition of the regulated article.<br />BPI inform the applicant if the information which the latter has identified as Commercial In Confidence (CIC) does not qualify for such treatment and&nbsp; provide it an opportunity for consultation and review of its decision prior to disclosure to any third party.<br />An applicant may refer to data or results from applications previously submitted by other applicants:<br />Provided, that (i) the information, data or results are not CIC, or (ii) if the otherwise, the previous applicants have given their consent in writing to the use of their confidential information, data or results.

Competent National Authorities, Other&nbsp; entities/organization

As stipulated in EO 514, public participation shall be applied to all stages of the biosafety decision-making process from the time the application is received. For applications on biotechnology activities related to research and development, limited primarily for contained use, notice of the filing of such application with the NCBP shall be sufficient, unless the NCBP deems that public interest and welfare requires otherwise.

DA AO No. 8 allows transboundary movement with non-parties. DA AO No. 8 was formulated consistent with the provision of the Cartagena Protocol on Biosafety, i.e. exportation/importation to non-Parties for research purposes.

Socio-economic considerations are addressed through the architecture of the Philippine biosafety system. For example,<br />1.&nbsp; &nbsp; &nbsp;&nbsp; The Institutional Biosafety Committees, whose membership includes representatives from the communities where an experimental release of the LMOs will be made. The community representatives are expected to advise the scientists in the IBC on concerns of their respective communities, including socio-economic ones.<br />2.&nbsp; &nbsp; &nbsp;&nbsp; The decision to release LMOs either for experimental or commercial purposes or to allow their entry for food/feed purposes is made by the Department of Agriculture, through the Bureau of Plant Industry. The DA is the government agency in charge of food self-sufficiency and in making sure that farmers are benefited by any technology that is introduced.<br />3.&nbsp; &nbsp; &nbsp;&nbsp; At all levels of the national regulatory system, from the NCBP down to the agency BCs (e.g., DOST-BC), various disciplines and agencies are involved either in an advisory capacity or as part of the decision-making process.<br /> In any case, despite the above, we believe that the Philippine biosafety system will benefit from the on-going international discussions on how to operationalize (as opposed to merely conceptual approaches) the integration of socio-economic considerations in the risk assessment process.

EO 514, the drafting and issuance of which UNEP funded, has brought in new participants in the biosafety decision-making process. It included the Department of Interior and Local Government, Department of Trade and Industry, and Department of Foreign Affairs. The entry of these new members will hopefully provide new perspectives in how to operationalize the wider inclusion of socio-economic considerations in the biosafety process.

On the selection of answers, we prefer a more precise system i.e. 1-4, 5-9, 10-14 etc. , instead of 1 or more, 5 or more, 10 or more etc.