Question # 15 Explanatory Comment:

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 which is being implemented by the Department of Science and Technology.

Question # 16 Explanatory Comment :

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.

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 Explanatory Comment:

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. Thereafter, the funding requirements shall be included in the yearly General Appropriations Bill submitted to Congress.  

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

Question # 25 Explanatory Comment:

The Department of Agriculture has no regulation for transit of GM agricultural crops/seeds at the moment. Most of the imports of GM seeds and commodities containing GMOs are destined for the Philippines. The Plant Quarantine Service (PQS) of the Department of Agriculture 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 # 31 Explanatory Comment:

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 # 32 Explanatory Comment:

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 # 34 Explanatory Comment:

The BPI Molecular Laboratory, at present, can handle protein based (Lateral strips) and DNA-based detection methods (Conventional PCR) of LMOs. Quantitative Analysis can be done pending acquisition of real time PCR.

Question # 35 Explanatory Comment:

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 # 48 Eplanatory Comment:

The Philippines prohibit importation of unapproved LMOs events.

Question # 51 Explanatory Comment :

The regulations for LMOs-FFP are the following:

1. DA Administrative Order No. 8s. 2002 (Section 11); Policy on Importation for Direct Use as Food or Feed, or for Processing

2. DA Memorandum Circular (MC) No. 8; Guidelines for the Phytosanitary Inspection of Regulated Articles for   Food , Feed and Processing, Pursuant to AO No. 8 (Series of 2002), "Rules and Regulations on the Importation and Release into the Environment of Plants and Plant Products Derived from the Use of Modern Biotechnology"

3. DA AO No. 22  s.2007; Amending Specific Sections of Part V of D.A. Administrative Order No. 8, s. 2002, "Approval Process for the Importation of Regulated Articles for Direct Use as Food or Feed, or for Processing"

4. DA AO No.31s. 2008. (Oct. 13, 2008 ); Adoption of codex principles for the risk analysis of foods derived  from modern biotechnology and the codex guideline for the conduct of food safety assessment of foods derived from recombinant -DNA plants

Question # 58 Explanatry Comment:

Approved LMOs  for direct use as food and feed or for processing (FFP) from Sept 12, 2007 up to date :

Soybean MON89788, Corn 3272, Soybean A2704-12,Corn MON89034,Soybean DP356043, Corn MIR162, Soybean CV127,Soybean A5547-127, Corn Bt11 x  corn GA21, Corn TC1507 x Corn 59122, Corn 59122 x Corn TC1507 x Corn NK 603, Corn Bt11 x Corn MIR604, Corn MIR604 x Corn GA21, Corn Bt11 x corn MIR604 x corn GA21,Corn MON89034 x corn NK603, Corn MON89034 x corn MON88017, Corn MON89034 x corn 1507 x corn 88017 x corn 59122, Corn NK603x corn T25, Corn Bt11 x corn MIR162 x corn GA21, Corn 3272 x corn Bt11 x corn MIR604 x corn GA21, Corn BT11 x corn MIR162 x corn MIR604 x corn GA21, Corn MON89034 x corn TC1507 x corn NK603, Corn Bt11 x corn MIR162 x corn TC1507 x corn GA21, Corn Bt 11 x DAS 59122 x MIR604 x TC1507 x GA21

Question # 64 Explanatory Comment:
 
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 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 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

In March 2007, the DA received a request from Greenpeace demanding the complete and immediate withdrawal of corn Mon863 from the global market; e.g., the Greenpeace demand for the government to withdraw corn MON 863 is based on the reinterpretation of statistical results performed by Seralini G.E. et al entitled  "New Analysis of Rat Feeding Study with GM Maize Reveals Signs of Hepatorenal Toxicity".Published by the CRIIGEN (Committee for Independent Research and Genetic Engineering).The authors alleged that the Monsanto submission in 2003 to the European Commission for authorization to market, was based on an erroneous analysis of the data of a 90-day rat feeding study…

Comprehensive risk assessment on the study re corn MON 863 vis-a-vis the original submission by Monsanto  was done  by five independent experts.  Based on their review, no adverse effects was identified on human and animal health or the environment and corn MON863 was confirmed to not adversely affect the health of rats.

The Philippines has a regulatory framework in place.

not applicable

Explanatory Comment

Question # 81:

Risk Assessment Guidelines takes into consideration the following:

(i) Codex Alimentarius guideline for the conduct of food safety assessment of foods derived from recombinanty-DNA Plants CAC/GL 45-2003

(ii) Cartagena Protocol on Biosafety

(iii) OECD Consensus Documents  (Compositional Consideration Documents, Biology Documents, Consideration for Environmental Risk Assessment and other relevant documents.)

Summary reports of the risk assessment conducted by the DA-BPI are found in the BCH.

Question # 89:

Not all the Risk Assessment reports are submitted to the BCH. Risk Assessment for Field Trials of LMOs has yet to be submitted pending clarification on the appropriate information vis a vis the prescribed format in the BCH, which for sometime kept on changing.

Concerns on the potential risks identified during the risk assessment process is addressed by establishing mitigating measures that should be implemented during the conduct of the field trial and during propagation.

These measures form part of the conditions for approval of applications on LMOs which the proponent has to comply with. 

Example of the condition is the implementation of insect resistance management in Bt corn and weed evolution monitoring in the case of herbicide resistant corn. 

The DA has adopted Annex 3 of the Codex Alimentarius Plant Guidelines issued in 2009 as the Standard for food safety assessment in situations of low-level presence of recombinant-DNA plant material in food and feed.

The DA is currently consulting stakeholders on the "Rules and Regulations in the Application of Annex 3 to the Codex Alimentarius Plant Guidelines".

Please also see Article 25 Question No. 175.

Permit conditions require proper identification, handling, packaging and transport of regulated articles. (DA AO No. 8, s.2002/ DA MC No. 8 s.2003 "Guidelines on the Phytosanitary  Inspection of Regulated Articles for Food, Feed and Processing Pursuant to DA AO No.8s.2002")

Regulated articles for contained, field test and propagation are clearly identified.

Documentation accompanying LMOs-FFPs  shall indicate that it is or may contain an LMO.

DA AO 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.

Activities undertaken for the development of human resources and institutional capacities in biosafety:

Training for DENR Staff on: Enhancing Competence in Addressing Issues on GMOs and IAS; (Luzon Group) June 13-17, 2011; (VisMin Group) July 18-22, 2011

Workshop on Insect Resistance Management Policy Review; June 23-24, 2011
Study Tour for the Kenya National Biosafety Authority; Manila, Los Baños, Laguna and Pampanga; May 16-20, 2011;
Seminar on Implementation Experience and Regulatory Compliance to DA AO No. 8; Los Baños, Laguna, February 15, 2011
Training for CNAs Staff and IBCs on Biosafety Assessment of Genetically Modified Organisms (GMOs); December 4-6, 2010; 
Workshop on the Biosafety Clearing House, 8-9 October 2010
Seminar on Environmental Risk Assessment of GM Crops; Quezon City; October 26, 2010;
Training for CNAs Staff and IBCs on Biosafety Assessment of Genetically Modified Organisms (GMOs); June 9-11, 2010;
Training for CNAs Staff and IBCs on Biosafety Assessment of Genetically Modified Organisms (GMOs); May 26-28, 2010;
Visit of Vietnamese Biosafety Regulators (Discussion on the National Biosafety Framework and Philippine Biosafety Regulation); Manila and Los Baños, Laguna; May 15-30, 2010; 
Asia Pacific Conference on Insect Resistance Management (IRM) for Bt Crops; Makati City; March 18-19, 2010;
Capacity Building for DENR Biosafety Unit on Environmental Risk Assessment and Post Commercial Monitoring of GMOs; Quezon City and Pamapanga; November 16-18, 2009;
Seminar on Low Level Presence (LLP) of Recombinant DNA Plant Material; Makati City; October 13-14, 2009;
Capacity Building on Biosafety for DOH; Tagaytay City; October 8-9, 2009;
Study Tour for WEMA (Water Efficient Maize for Africa); Manila, Pampanga and Los Baños; September 12-20, 2009;
Biosafety and Biosecurity Approaches in Relation to the Release of GMOs and Introduction of PHES; Los Baños, Laguna; August 17, 2009
Seminar-workshop on Communicating Biosafety for DOST Personnel; Los Baños, Laguna; June 24-25, 2009;
Briefing-cum-Presentation of the Philippine Biosafety Regulatory System and DOST Biotechnology Agenda to Nigerian Candidates; Taguig City; May 5, 2009; 
Biosafety Regulations: Experiences in Implementation Los Baños, Laguna; October 23-24, 2008;
Insect and Weed Resistance Management for Transgenic Crops; Isabela; May 26-27, 2008.

National Workshops on the Biosafety Clearing-House Project I;
BCH Information and Education Campaign (PAWB-DENR, Quezon City) August 7, 2008; (Cebu City) August 19, 2008;(Davao City) August 21, 2008;(General Santos City) December 4, 2008; (Davao City) December 5, 2008;

Section 7 of E.O. 514, provides mechanism for Public Participation:  "The concerned government departments and agencies, in developing and adopting biosafety policies, guidelines and measures and in making biosafety decisions, shall promote, facilitate, and conduct public awareness, education, meaningful, responsible and accountable participation. They shall incorporate into their respective administrative issuances and processes best practices and mechanisms on public participation in accordance with the following guidelines"

In DA AO 8, Section 8 G, Section 9 E and Section 12 D, Public Consultation is a requirement for application for field testing, propagation and direct use as food, feed, or processing.

The BCH Pilipinas is a tool that was established with the assistance of the UNEP-GEF in 2007 in support the policy on transparency by sharing, providing access to and exchange of information on pertinent laws, regulations on biosafety, as well as decisions made by the government on the use of LMOs for direct use, among others.

DA AO8 allows transboundary movement with non-parties. DA AO8 was formulated consistent with the provision of the Cartagena Protocol on Biosafety.

The BPI has received reports of illegal transboundary movement as follows:

The first one was an allegation on the presence of LL601 in rice to be imported from the US. While the alledged presence of LL601 in shipments of imported rice may have been a case of low level presence or unintentional transboundary movement, the Department of Agriculture did not have the policy and guidelines in place during that time to ascertain such allegation. The policy in place was DA AO8 No. 8s. 2002, "Rules and Regulations on the Importation of Plant and Plant Products Derived from the Use of Modern Biotechnology", which is a zero-tolerance regime for unapproved events. The DA formally adopted Annex 3 on Food Safety Assessment in Situations of Low Level Presence of RecombinantDNA Plant Material in Food, on January 2009 and is at the moment, working on comments received on the proposed draft "Rules and Regulations on the Application of Codex Annex 3" after having conducted sectoral and regional consultations from August to October 2011. The BPI ensured that shipments of rice during the relevant period i.e 2006-2008 did not contain LL601.

The second involved a declaration of unapproved event of corn (TC1507) for propagation as per the required declaration of GM content from the importer/technology developer (DA MC No. 8 Series 2003). The BPI quarantined the shipment and the shipment was disposed of accordingly.

The Principles of E.O. 514 includes in 2.5 Socio-economic, Cultural and Ethical Considerations, to wit: "The socio-economic, ethical and cultural benefits and risks, of modern biotechnology to the Philippines and its citizens, and in particular on small farmers, indigenous peoples, women, small and medium enterprises and the domestic scientific community, shall be taken into account in implementing the NBF".

Accordingly, the NCBP will create a Technical Working Group (TWG) to start work on the drafting of standards for the above principles consistent with internationally accepted standards.

Several socio-economic studies focusing on the cost and benefits of planting GM corn to farmers in the Philippines had been conducted prior to decisions to commercialize products of modern biotechnology. Studies indicate higher corn yield and income benefits to the farmers.    

The DA, DENR, DOST and DOH have submitted their concurrence to the Department of Foreign Affairs (DFA), on the signing of the Nagoya-Kuala Lumpur Supplemental Protocol on Liability and Redress.

The DFA has indicated that the Nagoya-Kuala Lumpur Supplemental Protocol provides flexibility in the crafting of the Administrative Rules and Regulations on Liability and Redress. An inter agency TWG and their legal experts will formulate the domestic framework for this purpose.     

The government departments concerned with LMO regulations have the inherent function to determine socio-economic considerations, in a context broader than Article 26.

Seminar series/fora on biotechnology and biosafety regulations are organized by other institutions/organizations. Public information and outreach programmes are included in the yearly activities of the CNAs, NAST and DA-Project Information Unit.