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CBD

Distr.

GENERAL

CBD/SBI/2/13

27 May 2018

ORIGINAL: ENGLISH

SUBSIDIARY BODY ON IMPLEMENTATION

Second meeting

Montreal, Canada, 9-13 July 2018

Item 13 of the provisional agenda*

MONITORING AND REPORTING (ARTICLE 33) AND ASSESSMENT AND REVIEW OF THE

EFFECTIVENESS OF THE CARTAGENA PROTOCOL ON BIOSAFETY (ARTICLE 35)

Note by the Executive Secretary

BACKGROUND

1. Article 33 of the Cartagena Protocol on Biosafety requires Parties to monitor the implementation

of their obligations under the Protocol and to report, at intervals to be determined by the Conference of the

Parties serving as the meeting of the Parties to the Protocol, on measures taken to implement the Protocol.

2. Article 35 of the Cartagena Protocol requires the Conference of the Parties serving as the meeting

of the Parties to the Cartagena Protocol on Biosafety (COP-MOP) to undertake, five years after the entry

into force of the Protocol and at least every five years thereafter, an evaluation of the effectiveness of the

Protocol, including an assessment of its procedures and annexes.

3. The Strategic Plan for the Cartagena Protocol on Biosafety for the period 2011-2020 (Strategic

Plan)1 was adopted by COP-MOP in 2010 through its decision BS-V/16. The Parties to the Protocol decided

that a mid-term evaluation of the Strategic Plan would be carried out five years after its adoption in

conjunction with the third assessment and review of the effectiveness of the Protocol, at the eighth meeting

of COP-MOP.

4. The present note aims at assisting the Subsidiary Body on Implementation in considering (a) a draft

revised format for the fourth national report under the Cartagena Protocol on Biosafety, and (b) a process

for the upcoming fourth assessment and review of the effectiveness of the Cartagena Protocol and the final

evaluation of the Strategic Plan. Section I provides a summary of the monitoring and reporting process

leading to the drafting of the revised format for the fourth national report under the Cartagena Protocol as

* CBD/SBI/2/1.

1 The Strategic Plan for the Cartagena Protocol on Biosafety for the period 2011-2020 is available online at

http://bch.cbd.int/protocol/issues/cpb_stplan_txt.shtml.

http://bch.cbd.int/protocol/decisions/?decisionID=12329

https://www.cbd.int/doc/c/6ce5/878e/5ffa49887c20c19961fe040a/sbi-02-01-en.pdf

http://bch.cbd.int/protocol/issues/cpb_stplan_txt.shtml

CBD/SBI/2/13

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contained in the annex. Section II provides a summary of the process undertaken for the third assessment

and review of the Protocol and the mid-term evaluation of the Strategic Plan, and a possible way forward.

Section III contains two sets of suggested recommendations of the Subsidiary Body on Implementation to

the ninth meeting of the Conference of the Parties serving as the meeting of the Parties to the Cartagena

Protocol with regard to (a) monitoring and reporting and (b) assessment and review.

I. MONITORING AND REPORTING: DRAFT REVISED FORMAT FOR THE

FOURTH NATIONAL REPORT UNDER THE CARTAGENA PROTOCOL ON

BIOSAFETY

5. In its decision BS-I/9, the meeting of the Parties to the Cartagena Protocol requested Parties to

submit their reports every four years, twelve months prior to the meeting of the Parties to the Protocol at

which the reports would be considered. To date, Parties to the Protocol have been requested to submit

national reports as follows: (a) an interim national report in 2005 (decision BS-I/9); (b) a first national report

in 2007 (decision BS-III/14); (c) a second national report in 2011 (decision BS-V/14); and (d) a third

national report in 2015 (decision BS-VII/14).

6. The format for the third national report, which was welcomed by Parties in decision BS-VII/14,

was the first format to include, in addition to questions related to the implementation of provisions of the

Protocol, questions related to the indicators of the Strategic Plan for the Cartagena Protocol on Biosafety

for the period 2011-2020 to facilitate the third assessment and review of the effectiveness of the Protocol

and the mid-term evaluation of the Strategic Plan.2

7. Following the third assessment and review of the Protocol and the mid-term evaluation of the

Strategic Plan, the Conference of the Parties serving as the meeting of the Parties to the Protocol requested

the Executive Secretary to develop a revised format for the fourth national report with a view to ensuring

that complete and accurate information was captured while striving to ensure the applicability of the

baseline information, as established in decision BS-VI/15, 3 for review by the Subsidiary Body on

Implementation and for consideration at the ninth meeting of the Parties to the Protocol, in particular by:

(a) Improving the formulation of questions for their clarity, providing further explanation

where necessary (decision CP-VIII/14);

(b) Eliminating the redundancy observed in the questions used for the third national report

(decision CP-VIII/14);

(c) Adding questions that address mainstreaming biosafety into national biodiversity strategies

and action plans, other policies and legislation (decision CP-VIII/14);

(d) Aligning the language of the relevant questions in the draft format with the adopted

operational definitions of the terms “unintentional transboundary movement” and “illegal transboundary

movement” (decision CP-VIII/16).

2 In decision BS-VII/3, the Conference of the Parties serving as the meeting of the Parties to the Cartagena Protocol decided to

combine the two processes.

3 In its decision BS-VI/15, the Conference of the Parties serving as the meeting of the Parties to the Cartagena Protocol decided

that the data and information contained in the analysis undertaken in the context of the second assessment and review of the

effectiveness of the Protocol would form the baseline for measuring progress in implementing the Protocol, in particular the

subsequent evaluation of the effectiveness of the Protocol and the mid-term evaluation of the implementation of the Strategic

Plan.

https://www.cbd.int/decision/mop/default.shtml?id=8291



https://www.cbd.int/doc/decisions/mop-07/mop-07-dec-14-en.pdf

https://bch.cbd.int/protocol/issues/cpb_stplan.shtml

https://bch.cbd.int/protocol/issues/cpb_stplan.shtml

https://www.cbd.int/decisions/?id=13248




CBD/SBI/2/13

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8. Further to addressing the specific issues requested in the decisions, questions related to liability and

redress have been included in the proposed draft revised reporting format in the light of the entry into force

of the Nagoya-Kuala Lumpur Supplementary Protocol on Liability and Redress. The additional questions

in the draft revised reporting format would enable Parties to provide information for the review of the

effectiveness of the Supplementary Protocol.4

9. Accordingly, the Secretariat has prepared a draft revised format for the fourth national report, as

presented in the annex. Information for cross-referencing the questions in the draft revised format is

available as document CBD/SBI/2/INF/22.

10. The Global Environment Facility has provided financial support to eligible Parties to assist in the

preparation and submission of their second and third national reports. This support was welcomed by the

meeting of the Parties to the Cartagena Protocol (e.g. decision CP-VIII/14, para. 2) and has played an

important role in the submission of national reports under the Protocol as recognized in decision BS-VI/14.

The Subsidiary Body on Implementation may thus wish to recommend to the meeting of the Parties to the

Cartagena Protocol to recommend to the Conference of the Parties to the Convention that, in providing

guidance to the financial mechanism, it invite the Global Environment Facility to make financial resources

available with a view to enabling eligible Parties to prepare and submit their fourth national reports.

II. ASSESSMENT AND REVIEW AND FINAL EVALUATION OF THE STRATEGIC

PLAN FOR THE CARTAGENA PROTOCOL ON BIOSAFETY

A. Summary of the process undertaken for the third assessment and review and mid-

term evaluation of the strategic plan for the Cartagena Protocol on Biosafety

11. In decision BS-VII/3, the COP-MOP set out a process for the third assessment and review of the

Protocol in conjunction with the mid-term evaluation of the Strategic Plan whereby it requested the

Subsidiary Body on Implementation to review the information gathered and analysed by the Executive

Secretary with input from the Compliance Committee and the Liaison Group on Capacity-Building.

12. The Secretariat undertook an in-depth comparative analysis of the information submitted by Parties

through their third national reports5 against the baseline data obtained during the second national reporting

cycle. 6 To facilitate the compilation, aggregation and analysis of the available data, the Secretariat

developed an online national report analyzer tool, which is available on the Biosafety Clearing-House7 for

the comparison of data in the third national reports against the baseline. Additionally, where appropriate,

data obtained from the Biosafety-Clearing House was used in the analysis of some indicators and compared

with similar data used in the analysis during the second reporting cycle.

13. At its thirteenth meeting, the Compliance Committee provided its input into the third assessment

and review of the Protocol and the mid-term evaluation of the Strategic Plan in response to the request

contained in BS-VII/3.8 The scope of the Compliance Committee’s input focused on:

4 Article 13 of the Supplementary Protocol requires that the Conference of the Parties serving as the meeting of the Parties to the

Cartagena Protocol undertake a review of the effectiveness of the Supplementary Protocol five years after its entry into force and

every five years thereafter, provided that information requiring such a review has been made available by Parties.

5 One hundred and five Parties had submitted their third national reports at the time when the analysis was done.

6 See decision decision BS-VI/15.

7 The data used to carry out the analysis can be viewed in the National Report Analyzer, available at

http://bch.cbd.int/database/reports/analyzer.

8 The input of the Compliance Committee is summarized in document UNEP/CBD/SBI/1/INF/34.

https://www.thegef.org/



http://bch.cbd.int/database/reports/analyzer

CBD/SBI/2/13

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(a) The progress made with respect to Operational Objective 3.1 of the Strategic Plan that

refers to the strengthening of the mechanisms for achieving compliance;

(b) The extent to which information in the Biosafety-Clearing House is reliable and up to

date;

(c) The experience gained by the Committee in implementing its supportive role as

specified in decision BS-V/1.

14. At its eleventh meeting, the Liaison Group prepared its contribution to the third assessment and

review and mid-term evaluation of the Strategic Plan. The Liaison Group examined a comparative analysis

prepared by the Secretariat9 of the status and trends in the implementation of each of the operational

objectives of the Strategic Plan except Operational Objective 3.1 on compliance, on the basis of the

indicators of the Strategic Plan.10

15. The Subsidiary Body on Implementation undertook a review of the information and conclusions

provided by the Liaison Group and Compliance Committee, and submitted its findings and

recommendations to the COP-MOP at its eighth meeting.

16. In decision CP VIII/15, COP-MOP welcomed the work and contribution from the different steps in

the process for the third assessment and review of the Protocol and mid-term evaluation of the Strategic

Plan, and requested the Compliance Committee to continue providing inputs to the final evaluation of the

Strategic Plan. In the same decision, COP-MOP called upon Parties, for the remaining period of the

Strategic Plan, to consider prioritizing the operational objectives relating to the development of biosafety

legislation, risk assessment, risk management, detection and identification of living modified organisms,

and public awareness, education and training in view of their critical importance in facilitating the

implementation of the Protocol.

B. Possible way forward for the fourth assessment and review and final evaluation of

the Strategic Plan for the Cartagena Protocol on Biosafety (2011-2020)

17. Building on the positive experience resulting from the process described in section II above, a

similar process may be considered as a way forward for undertaking the fourth assessment and review of

the Cartagena Protocol in combination with the final evaluation of the Strategic Plan.

18. The process would comprise the following steps:

(a) The Secretariat would analyse and synthesize information on the implementation of the

Protocol using the fourth national reports as a primary source, the Biosafety Clearing-House and, where

appropriate, additional data to facilitate the process, and compare the information against the baseline;

(b) The Liaison Group on Capacity-Building and the Compliance Committee would contribute,

in a complementary and non-duplicative manner, to the fourth assessment and review of the Cartagena

Protocol and the final evaluation of the Strategic Plan;

(c) The Subsidiary Body on Implementation would consider the contributions by the Liaison

Group and the Compliance Committee, and would submit its findings and recommendations for

consideration by the COP-MOP at its tenth meeting.

9 As document UNEP/CBD/BS/LG-CB/11/2.

10 The contribution of the Liaison Group is summarized in document UNEP/CBD/SBI/1/INF/35.


CBD/SBI/2/13

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III. SUGGESTED RECOMMENDATIONS

A. Monitoring and Reporting (article 33)

19. The Subsidiary Body on Implementation may wish to recommend that the Conference of the Parties

serving as the meeting of the Parties to the Cartagena Protocol at its ninth meeting adopt a decision along

the following lines:

The Conference of the Parties serving as the meeting of the Parties to the Cartagena Protocol on

Biosafety

1. Adopts the reporting format annexed hereto and requests Parties to use it for the fourth

national report on the implementation of the Cartagena Protocol on Biosafety;

2. Invites Parties to prepare their reports through a consultative process involving all relevant

national stakeholders, as appropriate;

3. Encourages Parties to respond to all questions in the reporting format, and stresses the

importance of the timely submission of fourth national reports in order to facilitate the fourth assessment

and review of the effectiveness of the Cartagena Protocol and the final evaluation of the Strategic Plan for

the Cartagena Protocol on Biosafety for the period 2011-2020;11

4. Requests Parties and invites other Governments to submit to the Secretariat their fourth

national report on the implementation of the Cartagena Protocol on Biosafety:

(a) In an official language of the United Nations;

(b) Twelve months prior to the tenth meeting of the Conference of the Parties serving as the

meeting of the Parties to the Protocol, which will consider the report;

(c) Preferably online through the Biosafety Clearing-House, or offline using the appropriate

form that will be made available by the Secretariat for this purpose, duly signed by the national focal point

for the Cartagena Protocol;

5. Recommends to the Conference of the Parties, in adopting guidance to the financial

mechanism, that it invite the Global Environment Facility to make available, in a timely manner, financial

resources to eligible Parties to facilitate the preparation and submission of their fourth national reports under

the Protocol.

B. Assessment and Review (article 35)

20. The Subsidiary Body on Implementation may wish to recommend that the Conference of the Parties

serving as the meeting of the Parties to the Cartagena Protocol at its ninth meeting adopt a decision along

the following lines:

The Conference of the Parties serving as the meeting of the Parties to the Cartagena Protocol on

Biosafety

1. Reiterates its invitation to Parties, for the remaining period of the Strategic Plan for the

Cartagena Protocol on Biosafety for 2011-2020, to consider prioritizing the operational objectives

relating to the development of biosafety legislation, risk assessment, detection and identification of

living modified organisms, and public awareness in view of their critical importance in facilitating

the implementation of the Protocol.

11 Decision BS-V/16, annex I.

https://bch.cbd.int/protocol/decisions/decision.shtml?decisionID=12329

CBD/SBI/2/13

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2. Decides that the fourth assessment and review of the Cartagena Protocol will be combined

with the final evaluation of the Strategic Plan for the Cartagena Protocol for the period 2011-2020.

3. Requests the Executive Secretary:

(a) To continue making improvements to the online national report analyzer tool to

facilitate the compilation, aggregation and analysis of the data in the fourth national reports and

other sources against related baseline data that was obtained during the second national reporting

cycle;

(b) To analyse and synthesize information on the implementation of the Protocol using

the fourth national reports as a primary source, the Biosafety Clearing-House and, where

appropriate, additional data to facilitate the fourth assessment and review of the Protocol in

conjunction with the final evaluation of the Strategic Plan, and make this information available to

the Liaison Group on Capacity-Building and the Compliance Committee.

4. Also requests the Liaison Group on Capacity-Building and the Compliance Committee,

working in a complementary and non-duplicative manner, to contribute to the fourth assessment

and review of the Cartagena Protocol and the final evaluation of the Strategic Plan, and to submit

their conclusions for consideration by the Subsidiary Body on Implementation.

5. Further requests the Subsidiary Body on Implementation, at its third meeting, to consider

the information provided and conclusions reached by the Liaison Group and the Compliance

Committee, and to submit its findings and recommendations to the Conference of the Parties

serving as the meeting of the Parties to the Cartagena Protocol at its tenth meeting with a view to

facilitating the fourth assessment and review of the Cartagena Protocol and the final evaluation of

the Strategic Plan for the Cartagena Protocol on Biosafety for the period 2011-2020.

CBD/SBI/2/13

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Annex

DRAFT REVISED FORMAT FOR THE FOURTH NATIONAL REPORT UNDER THE

CARTAGENA PROTOCOL ON BIOSAFETY

Origin of the report

1. Country: Philippines

Contact person submitting the report

2. Name: Fortunato T. de la Peña

3. Title: Secretary1

Chairman2

4. Organization:

Department of Science and Technology1

National Committee on Biosafety of the

Philippines2

5. Mailing address: Department of Science and Technology

General Santos Avenue, Bicutan, Taguig City 1631

6. Telephone: [+632 837 2939 ]

7. Fax: [+632 837 2937 ]

8. E-mail: [email protected]

9. Organizations/stakeholders who were

consulted or participated in the preparation

of this report:

Competent National Authorities (Department of Science and

Technology, Department of Agriculture, Department of

Environment and Natural Resources, Department of Health,

Department of Interior and Local Government, Department

of Trade and Industry), National government agencies,

Research and development councils, Scientific and academic

communities, Public research institutions, Industry groups,

Civil society organizations, Non-government organizations,

etc.

Submission

10. Date of submission: [ 16/September/2019 ]

11. Time period covered by this report: From 1 October 2015 to 16 September 2019

Signature of the reporting officer12 _____________________________________

12 This document is a protected form in MS Word format to enable further processing of the information contained therein by the

CBD Secretariat. Only text entries and checkboxes may be changed. Once you finish filling in the form, please save it and print

this first page for signature. This form is also available in the BCH for electronic submission at: [LINK TO BE ADDED]

mailto:[email protected]

IMPORTANT: To facilitate the analysis of the information contained in this report, it is recommended that Parties submit

the report online through the Biosafety Clearing-House or as an attachment to an e-mail in MS Word format, together

with a scanned copy of the first signed page, to the Secretariat at: [email protected].

Please do not send this report via fax or postal mail or in electronic formats other than MS Word.

mailto:[email protected]

CBD/SBI/2/13

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12. If your country is not a Party to the

Cartagena Protocol on Biosafety (CPB),

is there any national process in place

towards becoming a Party?

Yes

No

13. Here you may provide further details:

The Philippines signed the Cartagena Protocol on Biosafety on 24 May 2000. It was ratified

by the Philippines’ Senate on 05 October 2006 and entered into force on 03 January 2007.

Article 2 – General provisions

Article 2 requires each Party to take the necessary and appropriate legal, administrative and other

measures to implement its obligations under the Protocol.

14. Has your country introduced the

necessary measures for the

implementation of the Protocol?

National measures are fully in place

National measures are partially in

place

Only temporary measures have

been introduced

Only draft measures exist

No measures have yet been taken

15. Which specific instruments are in place

for the implementation of national

biosafety measures?

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

No instruments are in place

16. Has your country undertaken initiatives

to mainstream biosafety into national

biodiversity strategies and action plans,

other policies and legislation?

Yes: [Please see item 20]

No

CBD/SBI/2/13

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17. Has your country established a

mechanism for budget allocations for

the operation of its national biosafety

measures?

Yes

No

18. Does your country have permanent staff

to administer functions directly related

to biosafety?

Yes

No

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?

1 to 4

5 to 9

10 or more

Is this number adequate: Yes No

CBD/SBI/2/13

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20. Here you may provide further details on the implementation of Article 2 in your

country:

QUESTION 15

Biosafety regulations are not legislated but takes the form of Executive Issuances from the

Office of the President of the Republic of the Philippines. Implementation of biosafety policies

rests with the Government agencies involved in the biosafety decision-making process.

Biosafety regulatory system is already in place prior to the country’s signing and ratification of

the Cartagena Protocol on Biosafety. The issuance of Executive Order No. 430 signed in 20

October 1990 paved the way for the creation of a body that served as oversight in managing

activities involving genetic engineering experiments and field trials of GMOs. The biosafety

regulatory system was further strengthened with issuance of E.O. 514 on 17 March 2006: The

National Biosafety Framework-

Regulations: DOST-DA-DENR-DOH-DILG Joint Department Circular No. 1 series of 2016

(JDC 1 s2016) issued on March 15, 2016; our commitments to WTO-SPS (World Trade

Organization-Sanitary and Phytosanitary Measures); Adoption of Codex Alimentarius

guidelines and IPPC (International Plant Protection Convention) standards.

Executive Issuances: Executive Order 430, issued on 15 October 1990, Executive Order 514

Series of 2006;

Biosafety Guidelines: Philippine Biosafety Guidelines series No. 1 of 1990; The Philippine

Biosafety Guidelines for Contained Use of Genetically Modified Organisms (GMOs) revised

Edition issued on September 2014; Guidelines on Planned Release of Genetically Manipulated

Organisms (GMOs) and Potentially Harmful Exotic Species (PHES) issued on May 1998; The

Philippines Biosafety Guidelines on Containment of Transgenic Arthropods (2014).

Other laws, regulations that indirectly apply to GMOs: The Consumer Code, The Wildlife

Resources Conservation and Protection Act of 2001 (RA 9147), Plant Variety Protection Act,

Network of Integrated Protected Areas, etc.

QUESTION 16

The Department of Environment and Natural Resources (DENR) formulated the Philippine

Biodiversity Strategy and Action Plan (PBSAP). The country’s roadmap to conserve its

biodiversity which covers the mainstreaming of the Convention on Biological Diversity’s

(CBD) objectives into the national development and sectoral planning framework that includes

measurable targets for CBD commitments.

The DENR Biodiversity Management Bureau (BMB), acting as Secretariat to the PBSAP

implementation, and in coordination primarily with the CBD, will formulate guidance and

courses of action to ensure implementation of the biodiversity-related conventions in an

increasingly coherent manner, involving greater collaboration and cooperation among

convention parties, convention secretariats and key partners, leading to more efficiency and

effectiveness in achieving the aims of those conventions; and, second, increased collaboration

and cooperation in the implementation of the biodiversity-related conventions at all levels,

facilitated engagement with other sectors, and improved opportunities for mainstreaming

CBD/SBI/2/13

Page 12

biodiversity objectives into other policies and sectors (including through the United Nations

development assistance frameworks and in furtherance of the Sustainable Development Goals).

QUESTION 17

E.O. 514 mandates the Competent National Authorities: Department of Science and

Technology (DOST) Department of Environment and Natural Resources (DENR) Department

of Agriculture (DA) and the Department of Health (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. However, budget to support the operations of the

NCBP and its Secretariat were provided by the Department of Science and Technology whose

Secretary sits as Chair of the NCBP while other Departments’ budget to support their mandates

as provided for in E.O. 514 are rider to the respective Department’s national budget.

QUESTION 18 and 19

Very few permanent staff, Senior officials are involved in the decision making-making process.

Biosafety function is performed on top of their regular workload. Most of the staff working in

the biosafety regulations on GMOs are contractual personnel.

Article 5 – Pharmaceuticals

21. Does your country regulate the

transboundary movement, handling or

use of LMOs which are pharmaceuticals

to humans?

Yes

No


country:

Transboundary movement of pharmaceuticals for humans, though not covered by the Protocol,

are regulated by the Food and Drug Administration of the Department of Health.

Article 6 – Transit and Contained use

23. Does your country regulate the transit of

LMOs?

Yes

No

24. Does your country regulate the

contained use of LMOs?

Yes

No

25. Has your country taken a decision

concerning the import of LMOs for

contained use?

Yes

No

CBD/SBI/2/13

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country:

QUESTION 23

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.

Article VIII of the JDC 1 s2016 provides for guidelines on how to secure an SPS Import

Clearance for LMOs to be used for contained use, field trials, commercial propagation and

direct use as food, feed and for processing. Most shipments of GMOs destined to the

Philippines are required to be in the Registry of Approved regulated articles and during

shipment, are required to be accompanied by a Phytosanitary Certificate. In addition, as per

MC No.8 series of 2003 “Guidelines for the Phytosanitary Inspection of Regulated Articles

for Food, Feed and for Processing”, consignment shall be accompanied with GMO

declaration certificate indicating, among others, the GM events present in the shipment.

QUESTION 24

The Philippines have existing 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 and The Philippines Biosafety Guidelines for Containment of

Transgenic Arthropods issued on October 2014.

Articles 7 to 10: Advance Informed Agreement (AIA) and

intentional introduction of LMOs into the environment

27. 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

No

28. When acting as the Party of export, has

your country established legal

requirements for the accuracy of

information contained in the notification

provided by the exporter?

Yes

No

29. In the current reporting period, has your

country received a notification regarding

intentional transboundary movements of

LMOs for intentional introduction into

the environment?

Yes

No

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30. If you answered Yes to question 29, did

the notification(s) contain complete

information (at a minimum the

information specified in Annex I of the

Cartagena Protocol on Biosafety)?

Yes, always

In some cases only

No

31. If you answered Yes to question 29, has

your country acknowledged receipt of

the notification(s) to the notifier within

ninety days of receipt?

Yes, always

In some cases only

No


your country informed both the

notifier(s) and the BCH of its

decision(s)?

Yes, always

In some cases only

No


country taken a decision in response to

the notification(s) regarding intentional

transboundary movements of LMOs for

intentional introduction into the

environment?

Yes

No


many LMOs has your country approved

for import for intentional introduction

into the environment?

None

1 to 4

5 to 9

10 or more

35. If you answered under question 34 that

LMOs were approved, have all these

LMOs actually been imported into your

country?

Yes, always

In some cases only

No

36. If you answered Yes to question 34, what

percentage of your country’s decisions

fall into the following categories?

[ %] Approval of the import/use of the

LMO(s) without conditions

[100 %] Approval of the import/use of the

LMO(s) with conditions

[ %] Prohibition of the import/use of the

LMO(s)

[ %] Request for additional relevant

information

[ %] Inform the notifier that the period

for communicating the decision has

been extended

CBD/SBI/2/13

Page 15


your country has taken a decision to

approve the import with conditions or to

prohibit the import, were the reasons

provided?

Yes, always

In some cases only

No

38. 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:

The Bureau of Plant Industry (BPI) of the Department of Agriculture requires a biosafety

permit for LMOs for field test and propagation. The Biosafety permit for field testing is valid

for two (2) years while permit for propagation is valid for five (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 event should accompany the shipment upon arrival in the

Philippines.

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 does not require a domestic permit as

long as the said LMO is approved.

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 require a PQC consistent with Article 8 of the Cartagena Protocol on Biosafety.

Article 11 – Procedure for living modified organisms

intended for direct use as food or feed, or for processing (LMOs-FFP)

39. Does your country have law(s),

regulation(s) or administrative measures

for decision-making regarding domestic

use, including placing on the market, of

LMOs that may be subject to

transboundary movement for direct use

as food or feed, or for processing?

Yes

No

CBD/SBI/2/13

Page 16

40. Has your country established legal

requirements for the accuracy of

information to be provided by the

applicant regarding the domestic use,

including placing on the market, of




Yes

No

41. In the current reporting period, how

many decisions has your country taken

regarding domestic use, including

placing on the market, of LMOs that

may be subject to transboundary

movement for direct use as food or

feed, or for processing?

None

1 to 4

5 to 9

10 or more

42. Does your country have law(s),

regulation(s) or administrative measures

for decision-making regarding the

import of LMOs for direct use as food

or feed, or for processing?

Yes

No


many decisions has your country taken

regarding the import of LMOs for direct

use as food or feed, or for processing?

None

1 to 4

5 to 9

10 or more


country, including measures in case of lack of scientific certainty on potential adverse

effects of LMOs that may be subject to transboundary movement for direct use as food

or feed, or for processing:

QUESTIONS 39-42

The policy for the Direct Use of the Regulated Articles as Food, Feed, or for Processing and

policy on the importation and its approval process is stipulated under Article VII of the JDC 1

s2016. The Department of Agriculture (DA) has established legal requirements, as per JDC 1

s2016, for the accuracy of information to be provided by the applicant.

Article 12 – Review of decision


mechanism for the review and change

of a decision regarding an intentional

transboundary movement of LMOs?

Yes

No

CBD/SBI/2/13

Page 17


country reviewed and/or changed a

decision regarding an intentional

transboundary movement of an LMO?

Yes

No


many decisions were reviewed and/or

changed?

1 to 4

5 to 9

10 or more

48. If you answered Yes to question 46,

were any of the reviews triggered by a

request from the Party of export or the

notifier?

Yes

No


your country provide a response within

ninety days setting out the reasons for

the decision?

Yes, always

In some cases only

No


were any of the reviews initiated by

your country as the Party of import?

Yes

No


your country, within thirty days, inform

both the notifier and the BCH and set

out the reasons for the decision?

Yes, always

In some cases only

No


country:

Article II Section 3 Item B provides for the mechanism of review and change of a decision

regarding LMOs, stating “If new information on the regulated article and its effects on human

health and the environment becomes available, and such information is relevant and

significant, 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.” JDC 1 s2016

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.

Article 13 – Simplified procedure


mechanism for the application of the

simplified procedure regarding an

intentional transboundary movement of

LMOs?

Yes

No

CBD/SBI/2/13

Page 18


country applied the simplified

procedure?

Yes

No

55. If you answered Yes to question 54, for

how many LMOs has your country

applied the simplified procedure?

None

1 to 5

5 or more


your country informed the Parties

through the BCH of the cases where the

simplified procedure was applied?

Yes, always

In some cases only

No


country:

[We already have a biosafety regulatory systems for GMOs in place, hence we do not employ

any mechanism for the application of simplified procedure. ]

Article 14 – Bilateral, regional and multilateral agreements and arrangements

58. How many bilateral, regional or

multilateral agreements or arrangements

relevant to biosafety has your country

established with other Parties/non-

Parties?

None

1 to 4

5 to 9

10 or more

59. If you answered under question 58 that agreements or arrangements were established,

please provide a brief description of their scope and objective:


country:

[ Type your text here ]

Articles 15 & 16 – Risk Assessment and Risk Management

61. Does the domestic regulatory

framework of your country require risk

assessments of LMOs to be conducted?

Yes

No

CBD/SBI/2/13

Page 19

62. If you answered Yes to question 61, in

respect of which LMOs does the

requirement apply (select all that

apply)?

For imports of LMOs for intentional

introduction into the environment

For exports of LMOs for intentional

introduction into the environment

For imports of LMOs intended for

direct use as food or feed, or for

processing

For decisions regarding domestic

use, including placing on the market,

of LMOs that may be subject to

transboundary movements for direct

use as food or feed, or for processing

For imports of LMOs for contained

use

For exports of LMOs for contained

use

Other: [Please specify]


mechanism to conduct risk assessments

prior to taking decisions regarding

LMOs?

Yes

No


does the mechanism include procedures

to identify and/or train national experts

to conduct risk assessments?

Yes

No

Capacity building in risk assessment or risk management

65. How many people in your country have been trained in risk assessment, monitoring,

management and control of LMOs?

i. Risk assessment:

None

1 to 9

10 to 49

50 to 99

100 or more


CBD/SBI/2/13

Page 20

ii. Risk management:

None

1 to 9

10 to 49

50 to 99

100 or more


iii. Monitoring:

None

1 to 9

10 to 49

50 to 99

100 or more


66. Is your country using training material

and/or technical guidance for training in

risk assessment and risk management of

LMOs?

Yes

No

67. If you answered Yes to question 66, is

your country using the “Manual on Risk

Assessment of LMOs” (developed by

the CBD Secretariat) for training in risk

assessment?

Yes

No


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?

Yes

No

69. Does your country have specific needs

for further guidance on specific topics

of risk assessment of LMOs?

Yes: [Please specify]

No

70. Does your country have the capacity to detect, identify, assess the risk of and/or monitor

LMOs or specific traits that may have adverse effects on the conservation and

sustainable use of biological diversity, taking into account risks to human health?

CBD/SBI/2/13

Page 21

i. Detect: Yes

No

ii. Identify: Yes

No

iii. Assess the risk: Yes

No

iv. Monitor: Yes

No

Conducting risk assessment or risk management

71. 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?

i. Risk assessment: Yes

No

ii. Risk management: Yes

No


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?

Yes

No

73. Has your country adopted common

approaches or methodologies to risk

assessment in coordination with other

countries?

Yes

No

74. 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?

Yes

No

CBD/SBI/2/13

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75. In the reporting period, has your

country conducted any kind of risk

assessment of LMOs, including for

contained use, field trials, commercial

purposes, direct use as food, feed, or for

processing?

Yes

No


many risk assessments were conducted?

1 to 4

5 to 9

10 or more


please indicate the scope of the risk

assessments (select all that apply):

LMOs for contained use (in

accordance with article 3)

LMOs for intentional introduction

into the environment for

experimental testing or field trials

LMOs for intentional introduction

into the environment for commercial

purposes

LMOs for direct use as food

LMOs for direct use as feed

LMOs for processing



were risk assessments conducted for all

decisions taken on LMOs for


environment or on domestic use of




Yes, always

In some cases only

No

79. Has your country established

appropriate mechanisms, measures and

strategies to regulate and manage risks

identified in the risk assessment of

LMOs?

Yes

No

CBD/SBI/2/13

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80. Has your country taken appropriate

measures to prevent unintentional

transboundary movements of LMOs,

including such measures as requiring a

risk assessment to be carried out prior

to the first release of an LMO?

Yes

No

81. 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

No


mechanism for monitoring potential

effects of LMOs released into the

environment?

Yes

No

83. Does your country have the necessary

infrastructure (e.g. laboratory facilities)

for monitoring or managing LMOs?

Yes

No

84. Here you may provide further details on the implementation of Articles 15 and 16 in

your country:

Development of transgenic crops in the Philippines involves a tiered approach in the conduct

of risk assessment and undergo several stages of testing 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 stipulates that no regulated article shall be allowed to be imported

or released into the environment without the conduct of risk assessment in accordance with

the established guidelines. 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 adopts as risk assessment guidance the following: Executive Order No. 514 s.

2006, section 5.2.1 Principles of Risk Assessment; Item B, Section 3, Article II Biosafety

Decisions of the DOST-DA-DENR-DOH-DILG Joint Department Circular No.1, series of

2016’; Annex III of the Cartagena Protocol on Biosafety; Recommendations of the Panel of

Experts, Organisation for Economic Cooperation and Development (OECD); and Codex

Alimentarius Guidelines for the conduct of food safety assessment of Foods derived from

recombinant DNA plants CAC/GL 45-2003;

CBD/SBI/2/13

Page 24

Article 17 – Unintentional transboundary movements13 and emergency measures

85. Has your country established measures

to notify affected or potentially affected

States, the Biosafety Clearing-House

and, where appropriate, relevant

international organizations in case of a

release under its jurisdiction that leads,

or may lead, to an unintentional

transboundary movement of a LMO

that is likely to have significant adverse

effects?

Yes

No


many releases of LMOs occurred under

your country’s jurisdiction that led, or

may have led, to an unintentional

transboundary movement?

None

1 to 4

5 to 9

10 or more


a release occurred, has your country

notified affected or potentially affected

States, the Biosafety Clearing-House

and, where appropriate, relevant

international organizations?

Yes, always

In some cases only

No

88. Does your country have the capacity to

take appropriate response measures in

response to unintentional transboundary

movements?

Yes

No


many times has your country become

aware of an unintentional transboundary

movement into its territory?

None

1 to 4

5 to 9

10 or more

13 In accordance with the operational definition adopted in decision CP VIII/16, “‘Unintentional transboundary movement’ is a

transboundary movement of a living modified organism that has inadvertently crossed the national borders of a Party where the

living modified organism was released, and the requirements of Article 17 of the Protocol apply to such transboundary

movements only if the living modified organism involved is likely to have significant adverse effects on the conservation and

sustainable use of biological diversity, taking also into account risks to human health, in the affected or potentially affected

States.”

CBD/SBI/2/13

Page 25


country:

The Philippines’ biosafety 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 verify if the GM event(s) present are listed in the Bureau of Plant Industry

(BPI) Approval Registry.

Article 18 – Handling, transport, packaging and identification


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

No


require that documentation

accompanying LMOs-FFP, in cases

where the identity of the LMOs is not

known, clearly identifies that they may

contain LMOs and are not intended for


environment, as well as a contact point

for further information?

Yes

No



accompanying LMOs-FFP, in cases

where the identity of the LMOs is

known, clearly identifies that they

contain LMOs and are not intended for


environment, as well as a contact point

for further information?

Yes

No

94. If you answered Yes to question(s) 91,

92 and/or 93, what type of

documentation does your country

require for the identification of LMOs-

FFP?

Existing types of documentation

A stand-alone document

Existing or a stand-alone

document

CBD/SBI/2/13

Page 26



accompanying LMOs that are destined

for contained use clearly identifies them

as LMOs 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?

Yes

No


what type of documentation does your

country require for the identification of

LMOs that are destined for contained

use?



Existing or a stand-alone document



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?

Yes

No


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

99. Does your country have available any

guidance for the purpose of ensuring the

safe handling, transport, and packaging

of living modified organisms?

Yes

No

CBD/SBI/2/13

Page 27

100. Does your country have the capacity to

enforce the requirements of

identification and documentation of

LMOs?

Yes

No

101. How many customs officers in your

country have received training in the

identification of LMOs?

None

1 to 9

10 to 49

50 to 99

100 or more


102. Has your country established

procedures for the sampling and

detection of LMOs?

Yes

No

103. How many laboratory personnel in your

country have received training in

detection of LMOs?

None

1 to 9

10 to 49

50 to 99

100 or more


104. Does your country have reliable access

to laboratory facilities for the detection

of LMOs?

Yes

No

105. How many laboratories in your country

are certified for LMO detection?

None

1 to 4

5 to 9

10 to 49

50 or more


certified laboratories exist in your

country, how many of them are

currently operating in the detection of

LMOs?

None

1 to 4

5 to 9

10 to 49

50 or more

CBD/SBI/2/13

Page 28


country:

MC#7 s2003 provides that plants and plant products of GM origin intended for direct use as

food, feed or for processing must carry a certificate of GMO content issued by an authorized

body from the country of origin or by an accredited laboratory;

The BPI-NPQSD randomly checks importations of plant products as to their GM content,

particularly for commodities known to be genetically modified and commercially grown in

other countries.

There are three laboratories under the Plant Quarantine Service Division that conduct LMO

detection but have yet to be certified for that purpose. Two of these laboratories employ

protein test while only one laboratory, capable of performing molecular assay, is currently

undergoing the process of securing ISO17025 accreditation for LMO detection and

identification.

QUESTION 105

We have government designated laboratories for GM detection.

Section 41 of the JDC#1 s2016: Outside Experts and Accreditation of Laboratories - provides

procedures for coordination and consultation with international or government agencies

and/or public/private research institutes or laboratories, educational establishments and

individuals or entities with expertise relevant to biosafety.

Article 19 – Competent National Authorities and National Focal Points

108. 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

No

Not applicable (no competent

national authority was designated)

109. 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

No

CBD/SBI/2/13

Page 29

110. Has your country undertaken initiatives

to strengthen collaboration among

national focal points, competent

national authority(ies) and other

institutions on biosafety-related

matters?

Yes: [Meetings and consultation are

conducted between national focal

point and competent national

authorities to discuss issues related

to biosafety including coordination

process for the ntegrated approach in

implementing the CBD and its

conventions]

No


country:

The following information are provided in the Biosafety Clearing House:

Focal Point for Cartagena Protocol on Biosafety - United Nations International Organization-

Department of Foreign Affairs (UNIO/DFA)

Based on Executive Order No. 514 issued in 2006, the designated Competent National

Authorities (CNAs) are: National Committee on Biosafety of the Philippines, the lead body

coordinating the implementation of policies on biosafety; and government Departments

implementing biosafety policies on GMOs: Department of Agriculture, Department of

Environment and Natural Resources, Department of Health, and Department of Science and

Technology.

BCH National Focal Point is the Head Secretariat of the NCBP and serves as liaison with the

SCBD and the CNAs in making sure that country records are updated on a regular basis.

Focal Point for Emergency measures- Department of Agriculture-Bureau of Plant Industry

Article 20 – Information Sharing and the Biosafety Clearing-House (BCH)

112. 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.

a. Existing 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 and in the

BCH

Information available but not in the

BCH

Information available but only

partially available in the BCH

Information not available

CBD/SBI/2/13

Page 30

b. Legislation, regulations and guidelines

applicable to the import of LMOs

intended for direct use as food or feed,

or for processing (Article 11, paragraph

5)


BCH


BCH




c. Bilateral, multilateral and regional

agreements and arrangements (Article

14, paragraph 2, and Article 20,

paragraph 3 (b))


BCH


BCH




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))


BCH


BCH




e. Decisions by a Party regarding transit

of LMOs (Article 6, paragraph 1)


BCH


BCH




CBD/SBI/2/13

Page 31

f. Decisions by a Party regarding import

of LMOs for contained use (Article 6,

paragraph 2)


BCH


BCH




g. Notifications regarding the release

under your country’s jurisdiction that

leads, or may lead, to an unintentional

transboundary movement of a LMO

that is likely to have significant adverse

effects on biological diversity (Article

17, paragraph 1)


BCH


BCH




h. Information concerning cases of illegal

transboundary movements of LMOs

(Article 25, paragraph 3)


BCH


BCH




i. Decisions regarding the importation of

LMOs for intentional introduction into

the environment (Article 10, paragraph

3)


BCH


BCH




j. Information on the application of

domestic regulations to specific imports

of LMOs (Article 14, paragraph 4)


BCH


BCH




CBD/SBI/2/13

Page 32

k. Decisions regarding the domestic use of



as food or feed, or for processing



BCH


BCH




l. 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)


BCH


BCH




m. Declarations regarding the framework

to be used for LMOs intended for direct

use as food or feed, or for processing



BCH


BCH




n. Review and change of decisions

regarding intentional transboundary

movements of LMOs (Article 12,

paragraph 1)


BCH


BCH




CBD/SBI/2/13

Page 33

o. 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

(a))


BCH


BCH




p. LMOs granted exemption status by

each Party (Article 13, paragraph 1 (b))


BCH


BCH




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))


BCH


BCH




113. Please provide a brief explanation if you answered that the information is available but

not in the BCH or only partially available in the BCH to any item under question 112:

Parties are required to place all required information in the BCH as specified in Item 3 of

Article 20. Hence, we cannot determine what more information do we need to put in the BCH

as indicated in Question 113.


mechanism for strengthening the

capacity of the BCH National Focal

Point to perform its administrative

functions?

Yes

No

CBD/SBI/2/13

Page 34


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

No

116. Does your country use the information

available in the BCH in its decision

making processes on LMOs?

Yes, always

Yes, in some cases

No

Not applicable (no decisions were

taken)

117. Has your country experienced

difficulties accessing or using the BCH?

Yes: [Please refer to item 120.]

No

118. In the reporting period, how many

biosafety-related events (e.g. seminars,

workshops, press conferences,

educational events) has your country

organized?

None

1 to 4

5 to 9

10 to 24

25 or more

119. In the reporting period, how many

biosafety-related publications has your

country published?

None

1 to 9

10 to 49

50 to 99

100 or more

CBD/SBI/2/13

Page 35


country:

Established in 2008 in compliance with Article 20 of the Protocol, the Biosafety Clearing-

House Pilipinas contains 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: List of Biosafety Experts, Country Decisions or any other

Communications, National Database or Website, News, Risk Assessments and Country

decisions on Direct USe, and Reports on the Implementation of the Protocol.

QUESTION 117

The issue is not the difficulty in accessing the BCH but rather a technical glitch that we

observed specifically in the country’s record of biosafety experts.

CBD/SBI/2/13

Page 36

Article 21 – Confidential information

121. Has your country established procedures

to protect confidential information

received under the Protocol?

Yes

No

122. Does your country allow the notifier to

identify information that is to be treated

as confidential?

Yes, always

In some cases only

No

123. Here you may provide further details on the implementation of Article 21 in your country:

EO 514 series of 2006 and JDC 1 series of 2016 stipulates that concerned departments and

agencies 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.

BPI informs the applicant if the information marked as Commercial in Confidence (CIC) does

not qualify for such treatment and provides 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

124. Does your country have predictable and

reliable funding for building capacity for

the effective implementation of the

Protocol?

Yes

No

125. 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

No


how were these resources made

available?

Bilateral channels

Regional channels

Multilateral channels

CBD/SBI/2/13

Page 37

127. Has your country provided support to

other Parties in the development and/or

strengthening of human resources and

institutional capacities in biosafety?

Yes

No


were these resources made available?

Bilateral channels

Regional channels

Multilateral channels

129. In the reporting period, has your country

initiated a process to access GEF funds

for building capacity in biosafety?

Yes: [Funding support to the Proposed

multi-year Asia Regional Biosafety

Project for the sustainable

implementation of the CPB]

No


how would you characterize the process?

Very easy

Easy

Average

Difficult

Very difficult


country undertaken activities for the

development and/or strengthening of

human resources and institutional

capacities in biosafety?

Yes

No

CBD/SBI/2/13

Page 38

132. If you answered Yes to question 131, in

which of the following areas were these

activities undertaken (select all that

apply)?

Institutional capacity and human

resources

Integration of biosafety in cross-sectoral

and sectoral legislation, policies and

institutions (mainstreaming biosafety)

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

Liability and redress



country carried out a capacity-building

needs assessment?

Yes

No

134. Does your country still have capacity-

building needs?

Yes

No

CBD/SBI/2/13

Page 39


which of the following areas still need

capacity-building (select all that apply)?

Institutional capacity and human

resources

Integration of biosafety in cross-sectoral

and sectoral legislation, policies and

institutions (mainstreaming biosafety)

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

Sampling, detection and identification

of LMOs

Socio-economic considerations

Implementation of the documentation

requirements for handling, transport,

packaging and identification

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

Liability and redress

Other: [ Capacity building on risk

assessment, risk management, handling,

of products of new breeding

innovations]

136. Has your country developed a capacity-

building strategy or action plan?

Yes

No

137. Does your country have in place a

functional national mechanism for

coordinating biosafety capacity-building

initiatives?

Yes

No

CBD/SBI/2/13

Page 40

138. Here you may provide further details on the implementation of Article 22 in your country,

including further details about your experience in accessing GEF funds:

To implement the country’s regulatory framework consistent with the provisions of the Cartagena

Protocol on Biosafety, the NCBP thru the CNA’s continuously implements capacity building

program to enhance the regulatory system. Activities includes:

Training/enhancement activities for regulators in all aspects of biosafety regulation of

agricultural crops, GM animals and new breeding technologies

Awareness raising for policy makers on the issues and provide accurate information on

biosafety for enactment of appropriate laws. Regulations and programs

Awareness raising of the public on the measures put in place by the government to address

the issues and concerns on LMOs

Participation of the regulators in Webinars and On-line for a sponsored by the Secretariat

of the CBD, i.e. Socio Economic considerations, Risk assessment and risk management,

Synthetic Biology, Post 2020 Implementation Plan on Cartagena Protocol on Biosafety

Article 23 – Public awareness and participation

139. Is biosafety public awareness, education

and/or participation addressed in

legislation or policy in your country?

Yes

No


country cooperated with other States and

international bodies in relation to public

awareness, education and participation?

Yes: [Asia BCH Family]

No


mechanism to ensure public access to

information on LMOs?

Yes

No

142. Does your country have in place a

national communication strategy on

biosafety?

Yes

No

143. Does your country have any awareness

and outreach programmes on biosafety?

Yes: Competent National Authorities,

other entities/organizations

No

144. Does your country currently have a

national biosafety website?

Yes

No

CBD/SBI/2/13

Page 41

145. How many academic institutions in your

country are offering biosafety education

and training courses and programmes?

None

1 to 4

5 to 9

10 or more


146. How many educational materials and/or

online modules on biosafety are

available and accessible to the public in

your country?

None

1 to 4

5 to 9

10 to 24

25 to 99

100 or more



mechanism to consult the public in the

decision-making process regarding

LMOs?

Yes

No

148. Has your country informed the public

about existing modalities for public

participation in the decision-making

process regarding LMOs?

Yes

No


please indicate the modalities used to

inform the public:

National websites

Newspapers

Forums

Mailing lists

Public hearings

Other: [Social media]


many times has your country consulted

the public in the decision-making

process regarding LMOs?

None (decisions taken without

consultation)

1 to 4

5 or more


taken)

CBD/SBI/2/13

Page 42

151. Has your country informed the public

about the means to access the Biosafety

Clearing-House?

Yes

No

CBD/SBI/2/13

Page 43


As stipulated in Section 7 of E.O. 514, Public participation shall be applied to all stages of the

biosafety decision-making process from the time that the application is received;

For applications on R&D, notice of the filing of such application with the NCBP shall be

sufficient.

For field trial:

All applications and Biosafety Permits are posted in the NCBP and BPI websites, and in

offices of the DA and DOST in the province, city or municipality where the field trial will

be conducted

Project Information Sheet (PIS) are posted in three (3) conspicuous places within the

vicinity of the city/municipality and barangay where the proposed field trials will be

conducted, at least 2 weeks prior to the public hearing.

Public hearing is conducted in the place where the field trials are to be conducted.

Applicant is required to submit to the BPI, a written report on the public consultation.

For FFP:

• All applications and Biosafety Permits are posted in the NCBP and BPI websites,

and in offices of the DA and DOST nationwide.

• Approved PIS, notification and invitation to comment on the application for Direct Use

is published in two newspapers;

• Applicant submits to the BPI a written report on the public comments.

All decisions on R&D are uploaded in the DOST-BC website.

All decisions on FFPs are uploaded in the NCBP website.

Uploading of all decisions on field trials or intentional introduction into the environment are on-

going and are being done in coordination with the BPI.

QUESTION 140

The Philippines is part of a regional network of countries promoting information and awareness

on the Cartagena Protocol on Biosafety. The initiative dates back almost a decade ago by Korea

in support of the capacity building program on the Protocol. The Asia BCH Family (ABF), made

up of 23 Asian Countries aims to facilitate the implementation of the CPB by implementing and

sustaining the activities of the Asia BCH Roadmap (2016-2020) towards a vision of being self-

sustaining by year 2020 and beyond.

The Asia BCH Roadmap, developed in 2015, in Nanjing, Peoples Republic of China, embodies

the goal of the 23 Asian countries in the next five years to further its compliance with the

Cartagena Protocol, specifically on the four focal areas:

Compliance with the National Biosafety Framework and Cartagena Protocol

Enhancement of regional networking and cooperation

Promotion of public awareness, education and information

CBD/SBI/2/13

Page 44

Building capacity towards effective participation to the BCH

The Philippines served as regional coordinator for the implementation of the roadmap from 2016-

2017. Among the activities accomplished were:

Organized a side event entitled “For a successful Asia BCH Family” During COPMOP8

at Cancun, Mexico in December 2016.

Supported Nanjing Institute of Environmental Sciences in organizing a training on risk

assessment, LMO detection, and the BCH in September 2016

Created, launched and operationalize the ABF Regional Portal.

Organized a Regional Workshop back-to-back with the BCH III Workshop at Daejeon,

Republic of Korea in November 2017.

Provided support to the CBD on the online discussions on BCH: review of a Module on

Public Education regarding LMOs

Preparation is underway for select number of countries to sustain the activities in the region not

only on information sharing and the BCH but implement and collaborate in other thematic areas

thru a regional biosafety project.

Article 24 – Non-Parties

153. Has your country entered into any

bilateral, regional, or multilateral

agreement with non-Parties regarding

transboundary movements of LMOs?

Yes

No


imported LMOs from a non-Party?

Yes

No


exported LMOs to a non-Party?

Yes

No

156. If you answered Yes to question 154

and/or 155, were the transboundary

movements of LMOs consistent with the

objective of the Cartagena Protocol on

Biosafety?

Yes, always

In some cases only

No


[ Type your text here ]

Article 25 – Illegal transboundary movements14

14 In accordance with the operational definition adopted in decision CP VIII/16, “‘Illegal transboundary movement’ is a

transboundary movement of living modified organisms carried out in contravention of the domestic measures to implement the

Protocol that have been adopted by the Party concerned”.

CBD/SBI/2/13

Page 45

158. 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

No


many cases of illegal transboundary

movements of LMOs has your country

become aware of?

None

1 to 4

5 to 9

10 or more

160. If you indicated under question 159 that

your country became aware of cases of

illegal transboundary movements, has

the origin of the LMO(s) been

established?

Yes

Yes, some cases

No


The Philippines adopted measures aimed at preventing and/or penalizing transboundary

movements of LMOs carried out in contravention of its domestic measures;

During the current reporting period, there were no cases of illegal transboundary movements of

LMOs that has occurred in the country.

Article 26 – Socio-economic considerations

162. Does your country have any specific

approaches or requirements that facilitate

how socio-economic considerations

should be taken into account in LMO

decision making?

Yes

No

163. In the reporting period, have socio-

economic considerations arising from the

impact of LMOs been taken into account

in decision-making?

Yes, always

In some cases only

No


taken)

CBD/SBI/2/13

Page 46

164. 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?

None

1 to 4

5 to 9

10 to 49

50 or more


165. Has your country cooperated with other

Parties on research and information

exchange on any socio-economic

impacts of LMOs?

Yes

No


The Philippines acknowledges the draft “Guidance on the assessment of socio-economic

considerations in the context of Article 26 of the Cartagena Protocol on Biosafety.”

The Philippines conforms with the process-based approach adopted by the co-chairs of the Ad

Hoc Technical Expert Group (AHTEG) on socio-economic, considerations, in assessing the

impact of LMOs on the conservation and sustainable use of biological diversity, especially with

regard to the value of biological diversity to indigenous and local communities

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 decision making process.

Article 27 – Liability and Redress

167. Is your country a Party to the Nagoya-

Kuala Lumpur Supplementary Protocol on

Liability and Redress?

Yes

No

168. If you answered No to question 167, is

there any national process in place

towards becoming a Party?

Yes

No

169. Does your country have administrative or legal instruments that require response measures

to be taken:

a. In case of damage resulting from

LMOs?

Yes

No

b. In case there is sufficient likelihood

that damage will result if response

measures are not taken?

Yes

No

CBD/SBI/2/13

Page 47

170. If you answered Yes to question 169a, do

these instruments impose requirements

on an operator (select all that apply)?

Yes, the operator must inform the

competent authority of the damage

Yes, the operator must evaluate the

damage

Yes, the operator must take response

measures

Yes, other requirements: [Please

specify]

No

171. If you answered Yes to question 169b, do

these instruments require the operator to

take response measures to avoid damage?

Yes

No

172. If you answered Yes to question 169a or

169b, do these instruments provide for a

definition of ‘operator’?

Yes

No


which of the following could be an

‘operator’ (select all that apply)?

Permit holder

Person who placed the LMO on the

market

Developer

Producer

Notifier

Exporter

Importer

Carrier

Supplier


174. Has a competent authority been identified

for carrying out the functions set out in the

Supplementary Protocol?


No

CBD/SBI/2/13

Page 48


measures may the competent authority

take (select all that apply)?

Identify the operator that caused the

damage

Evaluate the damage

Determine response measures to be

taken by operator

Implement response measures

Recover costs and expenses of the

evaluation of the damage and the

implementation of any response

measures from the operator


176. Does your country have measures in place

to provide for financial security for

damage resulting from LMOs?

Yes

No


type of financial security measures are in

place (select all that apply)?

Requirement to provide evidence for

secure source of funding

Mandatory insurance

Government schemes, including funds


178. Does your country provide for rules and

procedures on civil liability that address

damage resulting from LMOs or has such

damage been recognized in court rulings

(select all that apply)?

Yes, in a civil liability instrument

Yes, in court rulings

Yes, in other instruments: [Philippine

laws on liability and compensation for

damages resulting injuries committed

on persons. ]

No

179. Have there been any occurrences of

damage resulting from LMOs in your

country?


No

180. If you answered Yes to question 179, have

response measures been taken?


No

CBD/SBI/2/13

Page 49

181. Here you may provide further details on any activities undertaken in your country towards

the implementation of the Nagoya-Kuala Lumpur Supplementary Protocol on Liability and

Redress:

A Technical Working Group was formally constituted by the NCBP in 2016 to assess the country's

preparedness in implementing the Protocol and to identify existing laws and policies in the country

that would address the damage.

Findings of the TWG on the NKLSP are:

1. There is no unified definition of damage to biological diversity arising from the use of

LMOs to date;

2. The NKLSP provides for an administrative law regime; necessitates to identify an agency

that is authorized to determine liability and impose measure for restoration or redress.

The Philippines has rules and procedures for addressing damage in general and that the Philippine

Biosafety Guidelines stipulate provisions on risk assessment and risk management which include,

submission of contingency plan and response measures in case of incidents, obligation and duty

of the proponent to inform the regulatory agencies of any incident arising from the use of LMOs

that can lead to damage to biological diversity as well as the duty to mitigate the risks.

Specifically, section 45 of the JDC#1 s2016 provides for Remedies in cases of violations of laws,

rules and regulations related to biosafety.

Article 28 – Financial Mechanism and Resources

182. In the reporting period, how much funding

(in the equivalent of US dollars) has your

country mobilized to support

implementation of the Cartagena Protocol

beyond the regular national budgetary

allocation?

Nothing

1 to 4,999 USD

5,000 to 49,999 USD

50,000 to 99,999 USD

100,000 to 499,000 USD

500,000 USD or more

Article 33 – Monitoring and reporting

Article 33 requires Parties to monitor the implementation of its obligations under the Cartagena

Protocol and to report to the COP-MOP on measures taken to implement the Cartagena Protocol

183. Does your country have in place a system

to monitor and enforce the

implementation of the Cartagena

Protocol?

Yes

No

Other information

CBD/SBI/2/13

Page 50

184. Please use this field to provide any other information on issues related to national

implementation of the Protocol, including any obstacles or impediments encountered.

The National Committee on Biosafety of the Philippines, the lead body in the development of

biosafety policies coordinate with the CNA’s regarding the implementation of the National

Biosafety Framework and the provisions of the Cartagena Protocol on Biosafety. The NCBP

ensures that compliance with international obligations on biosafety are met.

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.

Some questions are redundant. There is a need to add one more box in each questions/responses

that are "not applicable". Thank you very much.

__________

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