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Third National Report on the implementation of the Cartagena Protocol on Biosafety
Record information and status
Record ID
110316
Status
Published
Date of creation
2016-05-12 13:24 UTC (andrew.bowers@cbd.int)
Date of publication
2016-05-12 13:24 UTC (andrew.bowers@cbd.int)

Origin of report
1. Country
  • Philippines
Contact officer for report
Coordinates
Mario G. Montejo
Secretary/Chairman
Department of Science and Technology / National Committee on Biosafety of the Philippines
General Santos Avenue
Taguig City, Bicutan
Philippines, 1631
Phone:+632 837 2939
Fax:+632 837-2937
Email:mgmontejo@dost.gov.ph
Consulted stakeholders
9. Organizations/stakeholders who were consulted or participated in the preparation of this report
Competent National Authorities, national government agencies, local government units, research and development councils, scientific and academic communities, research institutions, industry groups, civil society organizations, non-government organizations, etc.
Submission
10. Date of submission
2016-04-21
11. Time period covered by this report
Start date
2011-10
11. Time period covered by this report
End date
2015-09
Party to the Cartagena Protocol on Biosafety
Is your country a Party to the Cartagena Protocol on Biosafety (CPB)?
  • Yes
Article 2 – General provisions
14. Has your country introduced the necessary legal, administrative and other measures for the implementation of the Protocol?
This question is relevant to indicators 1.1.1, 2.1.1, 2.1.2, and 3.1.2 of the Strategic Plan
  • A domestic regulatory framework is fully in place
15. If you indicated that a national biosafety framework exists in the above question, when did it become operational?
This question is relevant to the indicator 1.1.1 of the Strategic Plan
  • 2006
16. Which specific instruments are in place for the implementation of your national biosafety framework?
  • One or more national biosafety laws
  • One or more national biosafety regulations
  • One or more sets of biosafety guidelines
  • Other laws, regulations or guidelines that indirectly apply to biosafety
17. Has your country established a mechanism for the budgetary allocations of funds for the operation of its national biosafety framework?
  • Yes
18. Does your country have permanent staff to administer functions directly related to the national biosafety framework?
  • Yes
19. If you answered Yes to question 18, how many permanent staff members are in place whose functions are directly related to the national biosafety framework?
  • More than 10
20. Has your country’s biosafety framework / laws / regulations / guidelines been submitted to the Biosafety Clearing-House (BCH)?
  • Yes
21. Here you may provide further details on the implementation of Article 2 in your country
QUESTION 15
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.
QUESTION 16
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.
QUESTION 17
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.
QUESTIONS 18 and 19
Permanent staff per concerned agency and on top of their regular workload
Article 5 - Pharmaceuticals
22. Does your country regulate the transboundary movement, handling and use of living modified organisms (LMOs) which are pharmaceuticals?
  • No
24. Here you may provide further details on the implementation of Article 5 in your country:
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).
Article 6 – Transit and Contained use
25. Does your country regulate the transit of LMOs?
This question is relevant to indicator 1.8.1 of the Strategic Plan
  • Yes
26. Does your country regulate the contained use of LMOs?
This question is relevant to indicators 1.1.2 and 1.8.2 of the Strategic Plan
  • Yes
27. If you answered Yes to questions 25 or 26, has this information been submitted to the BCH?
  • No
28. Here you may provide further details on the implementation of Article 6 in your country:
QUESTION 25
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.
QUESTION 26
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
Articles 7 to 10 – Advance Informed Agreement (AIA) and intentional introduction of LMOs into the environment
29. Has your country adopted law(s) / regulations / administrative measures for the operation of the AIA procedure of the Protocol OR a domestic regulatory framework consistent with the Protocol regarding the transboundary movement of LMOs for intentional introduction into the environment?
This question is relevant to indicators 1.1.2 and 3.1.4 of the Strategic Plan
  • Yes
30. Has your country established a mechanism for taking decisions regarding first intentional transboundary movements of LMOs for intentional introduction into the environment?
  • Yes
31. If you answered Yes to question 30, does the mechanism also apply to cases of intentional introduction of LMOs into the environment that were not subject to transboundary movement?
  • Yes
32. Has your country established legal requirements for exporters under its jurisdiction to notify in writing the competent national authority of the Party of import prior to the intentional transboundary movement of an LMO that falls within the scope of the AIA procedure?
  • Yes
33. Has your country established legal requirements for the accuracy of information contained in the notification?
  • Yes
34. Has your country ever received an application / notification regarding intentional transboundary movements of LMOs for intentional introduction into the environment?
This question is relevant to indicator 1.1.4 of the Strategic Plan
  • Yes
35. Has your country ever taken a decision on an application / notification regarding intentional transboundary movements of LMOs for intentional introduction into the environment?
This question is relevant to indicator 1.1.5 of the Strategic Plan
  • Yes
36. If you answered Yes to question 35, how many LMOs has your country approved to date for import for intentional introduction into the environment?
  • Less than 5
37. If you answered Yes to question 35, how many LMOs, not imported, has your country approved to date for intentional introduction into the environment?
  • More than 10
38. In the current reporting period, how many applications/notifications has your country received regarding intentional transboundary movements of LMOs for intentional introduction into the environment?
  • Less than 5
39. In the current reporting period, how many decisions has your country taken regarding intentional transboundary movements of LMOs for intentional introduction into the environment?
  • Less than 5
40. With reference to the decisions taken on intentional transboundary movements of LMOs for intentional introduction into the environment, has your country received a notification from the Party(ies) of export or from the exporter(s) prior to the transboundary movement?
  • Yes
41. Did the notifications contain complete information (at a minimum the information specified in Annex I of the Cartagena Protocol on Biosafety)?
  • Yes
42. Has your country acknowledged receipt of the notifications to the notifier within ninety days of receipt?
  • Yes
43. Has your country informed the notifier(s) and the BCH of its decision(s)?
This question is relevant to indicator 3.1.5 of the Strategic Plan
  • In some cases only
44. What percentage of your country’s decisions fall into the following categories?
  • Approval of the import/use of the LMO(s) with conditions
100%
  • Request for additional relevant information
80%
45. In cases where your country approved an import with conditions or prohibited an import, did it provide reasons on which its decisions were based to the notifier and the BCH?
This question is relevant to indicator 3.1.5 of the Strategic Plan
  • In some cases only the notifier
46. Here you may provide further details on the implementation of Articles 7-10 in your country, including measures in case of lack of scientific certainty on potential adverse effects of LMOs for intentional introduction to the environment
QUESTION  30
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.
QUESTION 31
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.
QUESTION 32
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.
QUESTION 44
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.
Article 11 – Procedure for living modified organisms intended for direct use as food or feed, or for processing (LMOs-FFP)
47. Has your country adopted specific law(s) or regulation(s) for decision-making regarding domestic use, including placing on the market, of LMOs-FFP?
This question is relevant to indicator 1.1.2 of the Strategic Plan
  • Yes
48. Has your country established legal requirements for the accuracy of information to be provided by the applicant?
  • Yes
49. Has your country established a mechanism to ensure that decisions regarding LMOs-FFP that may be subject to transboundary movement will be communicated to the Parties through the BCH?
This question is relevant to indicator 3.1.5 of the Strategic Plan
  • Yes
50. Has your country established a mechanism for taking decisions on the import of LMOs-FFP?
This question is relevant to indicator 1.1.2 of the Strategic Plan
  • Yes
51. Has your country indicated its needs for financial and technical assistance and capacity-building in respect of LMOs-FFP?
This question is relevant to indicator 1.2.1 of the Strategic Plan
  • Yes
52. Has your country ever taken a decision on LMOs-FFP (either on import or domestic use)?
  • Yes
53. How many LMOs-FFP has your country approved to date?
  • More than 10
54. In the current reporting period, how many decisions has your country taken regarding the import of LMOs-FFP?
  • More than 10
55. In the current reporting period, how many decisions has your country taken regarding domestic use, including placing on the market, of LMOs-FFP?
  • More than 10
56. Has your country informed the Parties through the BCH of its decision(s) regarding import, of LMOs-FFP?
This question is relevant to indicator 3.1.5 of the Strategic Plan
  • Yes, always
57. Has your country informed the Parties through the BCH of its decision(s) regarding domestic use, including placing on the market, of LMOs-FFP within 15 days?
  • Yes, but with delays (i.e. longer than 15 days)
58. Here you may provide further details on the implementation of Article 11 in your country, including measures in case of lack of scientific certainty on potential adverse effects of LMOs-FFP
UESTION 47
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.
QUESTION 48
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.
Article 12 – Review of decision
59. Has your country established a mechanism for the review and change of a decision regarding an intentional transboundary movement of LMOs?
  • Yes
60. Has your country ever received a request for a review of a decision?
  • Yes
61. Has your country ever reviewed / changed a decision regarding an intentional transboundary movement of LMOs?
  • No
62. In the current reporting period, how many decisions were reviewed and/or changed regarding an intentional transboundary movement of an LMO?
  • None
66. Here you may provide further details on the implementation of Article 12 in your country
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
Article 13 – Simplified procedure
67. Has your country established a system for the application of the simplified procedure regarding an intentional transboundary movement of LMOs?
  • No
68. Has your country ever applied the simplified procedure?
  • No
70. In the current reporting period, how many LMOs has your country applied the simplified procedure to?
  • None
71. Here you may provide further details on the implementation of Article 13 in your country
The Philippines has a regulatory framework in place.
Article 14 – Bilateral, regional and multilateral agreements and arrangements
72. Has your country entered into any bilateral, regional or multilateral agreements or arrangements?
  • No
Articles 15 & 16 – Risk Assessment and Risk Management
77. Has your country established a national framework for conducting risk assessments prior to taking decisions regarding LMOs?
  • Yes
78. If you answered Yes to question 77, does this framework include procedures for identifying and/or training national experts to conduct risk assessments?
  • Yes
79. How many people in your country have been trained in risk assessment, monitoring, management and control of LMOs?
This question is relevant to indicator 2.2.3 of the Strategic Plan
a) Risk assessment:
  • 50 or more
b) Management / Control:
  • 50 or more
c) Monitoring:
  • 50 or more
80. Is your country using training material and/or technical guidance for training in risk assessment and risk management of LMOs?
This question is relevant to indicator 2.2.5 of the Strategic Plan
  • Yes
81. Is your country using the "Manual on Risk Assessment of LMOs" (developed by CBD Secretariat) for training in risk assessment?
This question is relevant to indicator 2.2.5 of the Strategic Plan
  • Yes
82. Is your country using the "Guidance on Risk Assessment of LMOs" (developed by the Online Forum and the AHTEG on Risk Assessment and Risk Management) for training in risk assessment?
This question is relevant to indicator 2.2.5 of the Strategic Plan
  • No
83. Are the currently available training materials or technical guidance on risk assessment and/or risk management of LMOs sufficient?
This question is relevant to indicator 2.2.6 of the Strategic Plan
  • Yes
84. Does your country have the capacity to detect, identify, assess and/or monitor living modified organisms or specific traits that may have adverse effects on the conservation and sustainable use of biological diversity, taking into account risks to human health?
This question is relevant to indicators 1.4.2 and 1.6.3 of the Strategic Plan
a) Detect:
  • Yes
b) Identify:
  • Yes
c) Assess:
  • Yes
d) Monitor:
  • Yes
85. Has your country adopted or used any guidance documents for the purpose of conducting risk assessment or risk management, or for evaluating risk assessment reports submitted by notifiers?
This question is relevant to indicators 1.3.1 of the Strategic Plan
a) Risk assessment:
  • Yes
b) Risk management:
  • Yes
86. Is your country using the "Guidance on Risk Assessment of LMOs" (developed by the Online Forum and the AHTEG on Risk Assessment and Risk Management) for conducting risk assessment or risk management, or for evaluating risk assessment reports submitted by notifiers?
This question is relevant to indicator 2.2.5 of the Strategic Plan
  • No
87. Has your country adopted any common approaches to risk assessment with other countries?
This question is relevant to indicator 1.3.2 of the Strategic Plan
  • Yes
88. Has your country cooperated with other Parties with a view to identifying LMOs or specific traits that may have adverse effects on the conservation and sustainable use of biological diversity?
This question is relevant to indicator 1.4.1 of the Strategic Plan
  • Yes
89. Has your country ever conducted a risk assessment of an LMO including any type of risk assessment of LMOs, e.g. for contained use, field trials, commercial purposes, direct use as food, feed, or for processing?
This question is relevant to indicator 1.3.3 of the Strategic Plan
  • Yes
90. If you answered Yes to question 89, please indicate the scope of the risk assessments (select all that apply):
  • Commercial production
  • Field trial
  • LMOs for Contained use
  • LMOs for direct use as food
  • LMOs for direct use as feed
  • LMOs for processing
91. If you answered Yes to question 89, were the summary reports of the risk assessments submitted to the BCH?
This question is relevant to indicator 3.1.5 of the Strategic Plan
  • In some cases only
92. If you answered Yes to question 89, were risk assessments conducted for all decisions taken on LMOs for intentional introduction into the environment or on domestic use of LMOs for direct use as food, feed, or for processing?
  • Yes, always
93. If you answered Yes to question 89, how many risk assessments were conducted in the current reporting period?
  • More than 10
94. Has your country taken measures to ensure that any LMO, whether imported or locally developed, undergoes an appropriate period of observation that is commensurate with its life-cycle or generation time before it is put to its intended use?
  • Yes, to some extent
Here you may provide further details
GM crops
95. Has your country established a mechanism for monitoring potential effects of LMOs that are released into the environment?
  • Yes
96. Does your country have the infrastructure (e.g. laboratory facilities) for monitoring or managing LMOs?
This question is relevant to indicator 2.2.4 of the Strategic Plan
  • Yes
97. Here you may provide further details on the implementation of Articles 15 and 16 in your country
GM development in the Philippines involves several stages, from contained use/confined test, field test and commercialization.
Risk assessment is conducted in all decisions taken for intentional transboundary movement of LMOs, be it domestic, propagation or FFP.
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.
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.
Article 17 – Unintentional transboundary movements and emergency measures
98. Has your country established and maintained appropriate measures to prevent unintentional transboundary movements of LMOs?
  • Yes
99. Has your country established a mechanism for addressing emergency measures in case of unintentional transboundary movements of LMOs that are likely to have significant adverse effect on biological diversity?
  • Yes
100. Does your country have the capacity to take appropriate measures in the event that an LMO is unintentionally released?
This question is relevant to indicator 1.8.3 of the Strategic Plan
  • Yes
101. In the current reporting period, how many times has your country received information concerning occurrences that led, or may have led, to unintentional transboundary movement(s) of one or more LMOs to or from territories under its jurisdiction?
  • Never
105. Here you may provide further details on the implementation of Article 17 in your country
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.
Article 18 – Handling, transport, packaging and identification
106. Has your country taken measures to require that LMOs that are subject to transboundary movement are handled, packaged and transported under conditions of safety, taking into account relevant international rules and standards?
  • Yes
107. Has your country taken measures to require that documentation accompanying LMOs-FFP clearly identifies that, in cases where the identity of the LMOs is not known through means such as identity preservation systems, they may contain living modified organisms and are not intended for intentional introduction into the environment, as well as a contact point for further information?
This question is relevant to indicator 1.6.1 of the Strategic Plan
  • Yes
108. Has your country taken measures to require that documentation accompanying LMOs-FFP clearly identifies that, in cases where the identity of the LMOs is known through means such as identity preservation systems, they contain living modified organisms and are not intended for intentional introduction into the environment, as well as a contact point for further information?
This question is relevant to indicator 1.6.1 of the Strategic Plan
  • Yes
109. If you answered Yes or Yes, to some extent to question(s) 107 and/or 108, what type of documentation does your country require for the identification of LMOs-FFP?
  • Existing or a stand-alone document
110. Has your country taken measures to require that documentation accompanying LMOs that are destined for contained use clearly identifies them as living modified organisms and specifies any requirements for the safe handling, storage, transport and use, the contact point for further information, including the name and address of the individual and institution to whom the LMO are consigned?
This question is relevant to indicator 1.6.2 of the Strategic Plan
  • Yes
111. If you answered Yes or Yes, to some extent to question 110, what type of documentation does your country require for the identification of LMOs that are destined for contained?
  • Existing or a stand-alone document
112. Has your country taken measures to require that documentation accompanying LMOs that are intended for intentional introduction into the environment of the Party of import, clearly identifies them as living modified organisms; specifies the identity and relevant traits and/or characteristics, any requirements for the safe handling, storage, transport and use, the contact point for further information and, as appropriate, the name and address of the importer and exporter; and contains a declaration that the movement is in conformity with the requirements of this Protocol applicable to the exporter?
This question is relevant to indicator 1.6.2 of the Strategic Plan
  • Yes
113. If you answered Yes or Yes, to some extent to question 112, what type of documentation does your country require for the identification of LMOs that are intended for intentional introduction into the environment?
  • Existing or a stand-alone document
114. Does your country have available any guidance for the purpose of ensuring the safe handling, transport, and packaging of living modified organisms?
This question is relevant to indicator 1.6.4 of the Strategic Plan
  • Yes
115. Does your country have the capacity to enforce the requirements of identification and documentation of LMOs?
  • Yes
116. How many customs officers in your country have received training in the identification of LMOs?
This question is relevant to indicator 2.3.1 of the Strategic Plan
  • None
117. Has your country established procedures for the sampling and detection of LMOs?
  • Yes
118. How many laboratory personnel in your country have received training in detection of LMOs?
This question is relevant to indicator 2.3.1 of the Strategic Plan
  • 10 or more
119. Does your country have reliable access to laboratory facilities for the detection of LMOs?
This question is relevant to indicator 2.3.2 of the Strategic Plan
  • Yes
120. How many laboratories in your country are certified for LMO detection?
This question is relevant to indicator 2.3.3 of the Strategic Plan
  • None
Article 19 – Competent National Authorities and National Focal Points
123. In case your country has designated more than one competent national authority, has your country established a mechanism for the coordination of their actions prior to taking decisions regarding LMOs?
  • Yes
124. Has your country established adequate institutional capacity to enable the competent national authority(ies) to perform the administrative functions required by the Cartagena Protocol on Biosafety?
  • Yes
125. Here you may provide further details on the implementation of Article 19 in your country
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.
Article 20 – Information Sharing and the Biosafety Clearing-House (BCH)
126. Please provide an overview of the status of the mandatory information provided by your country to the BCH by specifying for each category of information whether it is available and whether it has been submitted to the BCH.
This question is relevant to indicator 3.1.5 of the Strategic Plan
a) Existing national legislation, regulations and guidelines for implementing the Protocol, as well as information required by Parties for the advance informed agreement procedure (Article 20, paragraph 3 (a))
  • Information available but only partially available in the BCH
b) National laws, regulations and guidelines applicable to the import of LMOs intended for direct use as food or feed, or for processing (Article 11, paragraph 5)
  • Information available and in the BCH
c) Bilateral, multilateral and regional agreements and arrangements (Articles 14, paragraph 2 and 20, paragraph 3 (b))
  • Information not available
d) Contact details for competent national authorities (Article 19, paragraphs 2 and 3), national focal points (Article 19, paragraphs 1 and 3), and emergency contacts (Article 17, paragraph 3 (e))
  • Information available and in the BCH
e) Reports submitted by the Parties on the operation of the Protocol (Article 20, paragraph 3 (e))
  • Information available and in the BCH
f) Decisions by a Party on regulating the transit of specific living modified organisms (LMOs) (Article 6, paragraph 1)
  • Information not available
g) Occurrence of unintentional transboundary movements that are likely to have significant adverse effects on biological diversity (Article 17, paragraph 1)
  • Information not available
h) Illegal transboundary movements of LMOs (Article 25, paragraph 3)
  • Information not available
i) Final decisions regarding the importation or release of LMOs (i.e. approval or prohibition, any conditions, requests for further information, extensions granted, reasons for decision) (Articles 10, paragraph 3 and 20, paragraph 3(d))
  • Information available and in the BCH
j) Information on the application of domestic regulations to specific imports of LMOs (Article 14, paragraph 4)
  • Information not available
k) Final decisions regarding the domestic use of LMOs that may be subject to transboundary movement for direct use as food or feed, or for processing (Article 11, paragraph 1)
  • Information available and in the BCH
l) Final decisions regarding the import of LMOs intended for direct use as food or feed, or for processing that are taken under domestic regulatory frameworks (Article 11, paragraph 4) or in accordance with annex III (Article 11, paragraph 6) (requirement of Article 20, paragraph 3(d))
  • Information available and in the BCH
m) Declarations regarding the framework to be used for LMOs intended for direct use as food or feed, or for processing (Article 11, paragraph 6)
  • Information available and in the BCH
n) Review and change of decisions regarding intentional transboundary movements of LMOs (Article 12, paragraph 1)
  • Information available and in the BCH
o) LMOs granted exemption status by each Party (Article 13, paragraph 1)
  • Information not available
p) Cases where intentional transboundary movement may take place at the same time as the movement is notified to the Party of import (Article 13, paragraph 1)
  • Information not available
q) Summaries of risk assessments or environmental reviews of LMOs generated by regulatory processes and relevant information regarding products thereof (Article 20, paragraph 3 (c))
  • Information available and in the BCH
127. Has your country established a mechanism for strengthening the capacity of the BCH National Focal Point to perform its administrative functions?
  • Yes
128. Has your country established a mechanism for the coordination among the BCH National Focal Point, the Cartagena Protocol focal point, and the competent national authority(ies) for making information available to the BCH?
  • Yes
129. Does your country use the information available in the BCH in its decision making processes on LMOs?
  • Yes, always
130. Has your country experienced difficulties accessing or using the BCH?
This question is relevant to indicator 4.1.8 of the Strategic Plan
  • Yes
Here you may provide further details
Not reliable internet connection in the country
131. Is the information submitted by your country to the BCH complete and up-to date?
  • No
132. Please indicate the number of regional, national and international events organized in relation to biosafety (e.g. seminars, workshops, press conferences, educational events, etc.,) in the last 2 years:
This question is relevant to indicator 4.3.1 of the Strategic Plan
  • One or more
133. Please indicate the number of biosafety related publications that has been made available in your country in the last year:
This question is relevant to indicator 4.3.2 of the Strategic Plan
  • 10 or more
134. If biosafety related publications were made available (see question above), please indicate which modalities were preferred:
This question is relevant to indicator 4.3.2 of the Strategic Plan
  • National website
  • BCH Central Portal
  • National Libraries
135. Here you may provide further details on the implementation of Article 20 in your country
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.
Article 21 – Confidential information
136. Has your country established procedures to protect confidential information received under the Protocol?
  • Yes
137. Does your country allow the notifier to identify information that is to be treated as confidential?
  • Yes, always
138. Here you may provide further details on the implementation of Article 21 in your country
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.
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:
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,  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.
BPI inform the applicant if the information which the latter has identified as Commercial In Confidence (CIC) does not qualify for such treatment and  provide it an opportunity for consultation and review of its decision prior to disclosure to any third party.
An applicant may refer to data or results from applications previously submitted by other applicants:
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.
Article 22 – Capacity-building
139. Does your country have predictable and reliable funding for building capacity for the effective implementation of the Protocol?
This question is relevant to indicator 1.2.6 and 3.1.8 of the Strategic Plan
  • No
140. Has your country received external support or benefited from collaborative activities with other Parties in the development and/or strengthening of human resources and institutional capacities in biosafety?
  • Yes
141. If you answered Yes to question 140, how were these resources made available?
  • Bilateral channels
142. Has your country provided support to other Parties in the development and/or strengthening of human resources and institutional capacities in biosafety?
  • Yes
143. If you answered Yes to question 142, how were these resources made available?
  • Multilateral channels
144. Has your country ever initiated a process to access GEF funds for building capacity in biosafety?
  • Yes
145. If you answered Yes to question 144, how would you characterize the process?
Please add further details about your experience in accessing GEF funds under question 157.
  • Average
146. Has your country ever received funding from the GEF for building capacity in biosafety?
  • Development of national biosafety frameworks
  • Building Capacity for Effective Participation in the BCH (Phase I)
  • Building Capacity for Effective Participation in the BCH (Phase II)
147. During the current reporting period, has your country undertaken activities for the development and/or strengthening of human resources and institutional capacities in biosafety?
  • Yes
148. If you answered Yes to question 147, in which of the following areas were these activities undertaken?
  • Institutional capacity
  • Human resources capacity development and training
  • Risk assessment and other scientific and technical expertise
  • Risk management
  • Public awareness, participation and education in biosafety
  • Information exchange and data management including participation in the Biosafety Clearing-House
  • Scientific, technical and institutional collaboration at subregional, regional and international levels
  • Technology transfer
  • Identification of LMOs, including their detection
  • Socio-economic considerations
  • Implementation of the documentation requirements under Article 18.2 of the Protocol
  • Handling of confidential information
  • Measures to address unintentional and/or illegal transboundary movements of LMOs
  • Scientific biosafety research relating to LMOs
  • Taking into account risks to human health
149. During the current reporting period, has your country carried out a capacity-building needs assessment?
This question is relevant to indicator 1.2.1 of the Strategic Plan
  • Yes
150. If you answered Yes to question 149, has this information been submitted to the BCH?
This question is relevant to indicator 1.2.1 of the Strategic Plan
  • No
151. Does your country still have capacity-building needs?
This question is relevant to indicator 1.2.7 of the Strategic Plan
  • Yes
152. If you answered Yes to question 151, indicate which of the following areas still need capacity-building.
  • Institutional capacity
  • Human resources capacity development and training
  • Risk assessment and other scientific and technical expertise
  • Risk management
  • Public awareness, participation and education in biosafety
  • Information exchange and data management including participation in the Biosafety Clearing-House
  • Scientific, technical and institutional collaboration at subregional, regional and international levels
  • Technology transfer
  • Identification of LMOs, including their detection
  • Socio-economic considerations
  • Implementation of the documentation requirements under Article 18.2 of the Protocol
  • Handling of confidential information
  • Measures to address unintentional and/or illegal transboundary movements of LMOs
  • Scientific biosafety research relating to LMOs
  • Taking into account risks to human health
153. Has your country developed a capacity-building strategy or action plan?
This question is relevant to indicator 1.2.2 of the Strategic Plan
  • No
154. Does your country have in place a functional national mechanism for coordinating biosafety capacity-building initiatives?
This question is relevant to indicator 1.2.4 of the Strategic Plan
  • Yes
155. How many biosafety short-term training programmes and/or academic courses are offered annually in your country?
This question is relevant to indicator 1.2.3 of the Strategic Plan
  • 1 per year or more
156. Has your country submitted the details of national biosafety experts to the Roster of Experts in the BCH?
  • Yes
Article 23 – Public awareness and participation
158. Has your country established a strategy or put in place legislation for promoting and facilitating public awareness, education and participation concerning the safe transfer, handling and use of LMOs?
  • Yes
159. Has your country designed and/or implemented an outreach/communication strategy on biosafety?
This question is relevant to indicator 5.3.2 of the Strategic Plan
  • Yes
160. Does your country have any awareness and outreach programmes on biosafety?
This question is relevant to indicator 5.3.1 of the Strategic Plan
  • Yes
161. If you answered Yes to question 160, please indicate what entity is responsible for carrying out the programmes and/or services and at which level the programmes take place (e.g. local, national, etc.):
This question is relevant to indicator 5.3.1 of the Strategic Plan
Competent National Authorities, Other  entities/organization
162. Has your country established a biosafety website searchable archives, national resource centres or sections in existing national libraries dedicated to biosafety educational materials?
This question is relevant to indicators 2.5.3 and 5.3.3 of the Strategic Plan
  • Yes
163. How many collaborative initiatives (including joint activities) on the Cartagena Protocol and other Conventions and processes has your government established in the last 4 years?
This question is relevant to indicator 5.2.1 of the Strategic Plan
  • One or more
164. Has your country established a mechanism to ensure public access to information on living modified organisms that may be imported?
  • Yes
165. Has your country established a mechanism to consult the public in the decision-making process regarding LMOs?
This question is relevant to indicator 2.5.1 of the Strategic Plan
  • Yes
166. Has your country established a mechanism to make available to the public the results of decisions taken on LMOs?
This question is relevant to indicator 2.5.1 of the Strategic Plan
  • Yes
167. Has your country informed the public about existing modalities for public participation in the decision-making process regarding living modified organisms?
This question is relevant to indicator 2.5.2 of the Strategic Plan
  • Yes
168. If you answered Yes to question 167, please indicate the modalities used to inform the public:
This question is relevant to indicator 2.5.2 of the Strategic Plan
  • National website
  • Newspaper
  • Forums
  • Public notifications
169. If you indicated more than one modality for public participation in question 168, which one was most used?
This question is relevant to indicator 2.5.2 of the Strategic Plan
  • National website
170. Has your country taken any initiative to inform its public about the means of public access to the Biosafety Clearing-House?
  • Yes
171. How many academic institutions in your country are offering biosafety education and training courses and programmes?
This question is relevant to indicator 2.7.1 of the Strategic Plan
  • 3 or more
172. Please indicate the number of educational materials and/or online modules on biosafety that are available and accessible to the public in your country:
This question is relevant to indicators 2.7.2 and 5.3.4 of the Strategic Plan
  • 10 or more
173. In the current reporting period, has your country promoted and facilitated public awareness, education and participation concerning the safe transfer, handling and use of LMOs?
  • Yes
174. If you answered Yes to question 173, has your country cooperated with other States and international bodies?
  • Yes
175. In the current reporting period, how many times has your country consulted the public in the decision-making process regarding LMOs and made the results of such decisions available to the public?
  • More than 5
176. Here you may provide further details on the implementation of Article 23 in your country
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.
Article 24 – Non-Parties
177. Has your country entered into any bilateral, regional, or multilateral agreement with non-Parties regarding transboundary movements of LMOs?
  • No
178. Has your country ever imported LMOs from a non-Party?
  • Yes
179. Has your country ever exported LMOs to a non-Party?
  • Yes
180. If you answered Yes to questions 178 or 179, were the transboundary movements of LMOs consistent with the objective of the Cartagena Protocol on Biosafety?
  • Yes
181. If you answered Yes to questions 178 or 179, was information about these transboundary movements submitted to the BCH?
  • No
183. Here you may provide further details on the implementation of Article 24 in your country:
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.
Article 25 – Illegal transboundary movements
184. Has your country adopted domestic measures aimed at preventing and/or penalizing transboundary movements of LMOs carried out in contravention of its domestic measures to implement this Protocol?
  • Yes
185. Has your country established a strategy for detecting illegal transboundary movements of LMOs?
  • Yes
186. In the current reporting period, how many times has your country received information concerning cases of illegal transboundary movements of an LMO to or from territories under its jurisdiction?
If you replied Never to question 186 please go to question 191
  • Never
Article 26 – Socio-economic considerations
192. Does your country have any specific approaches or requirements that facilitate how socio-economic considerations should be taken into account in LMO decision making?
This question is relevant to indicator 1.7.2 of the Strategic Plan
  • Yes
193. If your country has taken a decision on import, has it ever taken into account socio-economic considerations arising from the impact of the LMO on the conservation and sustainable use of biological diversity?
  • Yes
194. How many peer-reviewed published materials has your country used for the purpose of elaborating or determining national actions with regard to socio-economic considerations?
This question is relevant to indicator 1.7.1 of the Strategic Plan
  • 5 or more
195. What is your country's experience, if any, in taking socio-economic considerations into account in LMO decision making? Please give details:
This question is relevant to indicator 1.7.3 of the Strategic Plan
Socio-economic considerations are addressed through the architecture of the Philippine biosafety system. For example,
1.       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.
2.       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.
3.       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.
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.
196. Has your country cooperated with other Parties on research and information exchange on any socio-economic impacts of LMOs?
  • Yes
197. Here you may provide further details on the implementation of Article 26 in your country
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.
Article 27 – Liability and Redress
198. Has your country ratified or acceded to the Nagoya-Kuala Lumpur Supplementary Protocol on Liability and Redress?
  • No
199. If you answered No to question 198, is there any national process in place towards becoming a Party?
  • No
200. Has your country received any financial and/or technical assistance for capacity-building in the area of liability and redress relating to living modified organisms?
This question is relevant to indicator 2.4.1 of the Strategic Plan
  • No
201. Does your country have administrative or legal instrument that provide for response measures for damage to biodiversity resulting from living modified organisms?
This question is relevant to indicators 1.5.2 and 2.4.2 of the Strategic Plan
  • Yes
Article 28 – Financial Mechanism and Resources
203. How much additional funding (in the equivalent of US dollars) has your country mobilized in the last four years to support implementation of the Biosafety Protocol, beyond the regular national budgetary allocation?
This question is relevant to indicator 1.2.5 of the Strategic Plan
  • 500,000 USD or more
Article 33 – Monitoring and reporting
204. Does your country have in place a monitoring and/or an enforcement system for the implementation of the Cartagena Protocol?
This question is relevant to indicator 3.1.6 of the Strategic Plan
a) Monitoring system:
  • Yes
b) Enforcement system:
  • Yes
205. Has your country submitted all the previous due National Reports?
  • Yes
Comments on reporting format
185. Please use this field to provide any other information on difficulties that you have encountered in filling in this report
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.