2015 Annual Report

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WHAT’S INSIDE?

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DOST-BC 2015 Projects

Scientific and Biosafety Policy Function

Capacity Building Policy Function

Study Visit in Brazil

DOST-BC, BPI conduct workshop on contained use monitoring

DOST-BC publishes contained use guidelines and circulars

List of DOST-BC Ongoing Projects

Members of the Department of science and technology - Biosafety Committee

The Secretariat

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DEPARTMENT OF SCIENCE AND TECHNOLOGY - BIOSAFETY COMMITTEE

Consistent with the mandate under Executive Order No. 514, the Department of Science and Technology-Biosafety Committee (DOST-BC) was established to take the lead in ensuring that the best available science is utilized and applied in adopting biosafety policies, measures and guidelines and in making biosafety decisions.

Functions In coordination with other concerned departments and agencies, the DOST-BC is conferred with the following functions:

• Ensure that policies, measures, guidelines and biosafety decisions are based on scientific information that is of the highest quality, multi-disciplinary, peer-reviewed, and consistent with international standards;

• Ensure that policies, measures, guidelines and biosafety decisions are consistent with the requirements of transparency and public participation;

• Conducts risk assessment of applications for contained use experiments, i.e. laboratory, greenhouse, screenhouse, glasshouse, insectary, and confined field, of genetically modified organisms (GMOs); and,

• Evaluate and monitor contained use experiments of GMOs. Composition To ensure that various concerns and issues are addressed during the risk assessment process of applications on GMOS, the DOST-BC members are appointed bjased on their respective field of expertise. Regulatory agencies are also represented in the DOST-BC so that they can be involved in the first-level of risk assessment of GMOs.

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Scientific and Biosafety Policy FunctionThe Department of Science and Technology-Biosafety Committee (DOST-BC) undertake its functions in relation to activities involving contained use and confined tests of genetically modified organisms (GMOs). The DOST-BC conducts science-based risk assessment of project proposals to identify and evaluate potential hazards involved in the proposed activities and recommends measures to minimize risks. The DOST-BC oversee the safe and responsible implementation of approved projects by ensuring that the biosafety measures prescribed by the Committee are strictly adhered to by the proponents. Implementation and monitoring of these projects are done in coordination with the Institutional Biosafety Committees and Plant Quarantine officers of the Bureau of Plant Industry.

In 2015, the DOST-BC approved nine projects, four of which were destined for contained use and five for confined test. By the end of 2015, a total of 44 ongoing projects (Annex I), including those that were approved from 2008 to 2014, are monitored under the supervision of DOST-BC.

The Committee likewise continued to review and approve the composition of Institutional Biosafety Committees (IBC). An IBC is established in every organization, public or private, that intends to do work with GMOs. It is composed of five (5) members; at least three (3) are technical persons who are affiliated with the institution and at least two (2) community representatives who shall represent the interest of the community where the experiment will be carried out. The IBC is tasked to review work to be implemented or sponsored by the institution and endorses the same for approval by the DOST-BC. It reviews containment requirements, facilities, procedures and practices, and training and expertise of personnel assigned to do the work. The IBC monitors projects, with respect to compliance with biosafety measures, and reports to the DOST-BC any significant problems/violations of the guidelines encountered during implementation. At present, there are nine active IBCs under the DOST-BC.

The DOST-BC also published two guidelines: (1) The Philippines Biosafety Guidelines for Contained Use of GMOs, revised edition and (2) The Philippines Biosafety Guidelines for Containment of Transgenic Arthropods. In addition, three (3) DOST-BC Circulars were issued on implementation of approved projects; amendments on posting of Project Information Sheet for purposes of public notification and comment; and, on transplanting activity of approved confined test These guidelines and procedures continuously evolve to address the rapid advances in the field of genetic modification.

Capacity Building FunctionThe DOST-BC provides capacity-building activities to its members and to other regulatory agencies, especially in conducting risk assessment and determining appropriate compliance with biosafety measures and protocols. In 2015, the DOST-BC has was able to reach out to new IBCs established for the Golden Rice Project, particularly the IBCs of PhilRice-Isabela and PhilRice-Batac. Moreover, it has also continuously collaborate with the Bureau of Plant Industry, which supervises compliance with the Plant Quarantine Law, in harmonizing monitoring procedures that will ensure that biosafety measures are in place in covered activities involving GMOs.

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Through the study visit, the DOST-BC delegation achieved the following objectives:

• Met with Brazilian biosafety and biotechnology regulators from the National Technical Biosafety Commission and shared experiences, gained insights on the Brazilian regulatory system particularly on how Brazil adopted the technology and became the second leading producer of GM crops in such a short span of time considering that the country was initially against the technology;

• Gathered information on the regulations of GMOs used, not only for agricultural crops but for industrial purposes as well; and,

• Visited the experimental facilities and biotech centers of excellence such as EMBRAPA, the Sugar Research Center and trials site for transgenic sugar, GM mosquito production unit and Amarys, the large-scale fermentation systems and facilities for biofuel production.

The study tour to Brazil offered a lot of opportunities for information acquisition in terms of recent developments in agri-biotechnology, implementation of the regulatory system on GMOs and international positioning and negotiations under the Cartagena Protocol as an offshoot of this activity, the DOST-BC Study Team made the following recommendations:

After being in operation for twenty fives, it is high time to revisit the organizational structure of the Philippine Biosafety System vis-à-vis the organizational structure of the Brazilian national Biosafety Technical Commission (CTNBio). The CTNBio is under one roof, the Ministry of Science, Technology and Innovation. Under the single Ministry, CTNBio is responsible in implementing in continuum all GM products from the R&D phase to commercial approvals. Thus, it is predictable when a GM event will be commercialized. In the Philippines, the system is truncated. The R&D phase is a responsibility of the DOST, while commercial approvals for crops are under the domain of BPI-DA. A further insight in the variance of the Brazilian System and the Philippine regulatory system lies in the creation of National Biosafety Council (CNBS), in Brazil, which is the highest policy making body on Biosafety. The equivalent of CNBS in the Philippines is the National Committee on Biosafety of the Philippines (NCBP). The head of the CNBS is a non-government person and appointed by the President. It is composed of 11 Ministers, and operates under the Authority of the Office of the President. The NCBP on the other hand, is chaired by the Secretary of DOST, and is composed of the Secretaries of the seven Departments making them co-equal in terms of authority and policy making function. Socio-economic considerations is decided at the CNBS level.

We also have to develop a formal collaboration between the DOST and the DFA, and provide an avenue for greater involvement of the Philippine Embassy in Brasilia in modern biotechnology and Biosafety matters. Many technologies now in commercial use in Brazil may be acquired and utilized in the Philippines.

The country’s delegation visited GM Sugarcane Research and Amarys Industrial Facilities in Sao Paulo, Brazil.

The DOST-BC recognizes the need to continuously enhance its technical capability to address issues and regulatory concerns on plant and plant products and other GMOs as well, specifically those in the pipeline. As part of this continuing initiative, the Committee sent a three-man delegation to Brazil from 27 July to 1 August 2015.

Aedes aegypti OX513A. Genetically engineered line of Aedes aegypti developed to suppress the mosquito that transmits dengue, chikungunya, zika and yellow and proven to suppress 96% of the mosquito population in the Cayman Islands.

Study Visit in Brazil

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7These would include biotechnological developments in sugar cane, bioethanol production, GM mosquito deployment against dengue, GM seed technology and biodiesel and fine chemical production using synthetic biology. His Excellency Ambassador Jose de la Rosa Burgos has shown great interest in opening official channels for continuous collection and exchange of information on biotechnology and other potentially useful technologies with CTNBio, for monitoring developments of other technologies, and in ensuring that the Philippines and Brazil remain strong allies and continue supporting each other’s stance in the negotiations for the Risk Assessment and

Risk Management of LMOs (Articles 15 and 16), and in the evolving Articles on socio-economic considerations in the Cartagena Protocol on Biosafety. In view of this, it is further recommended that His Excellency Ambassador Burgos be requested to join the Philippine delegation to the COP/MOP 8 in December 2016 in Cancun, Mexico.

The study group finds that synthetic biology has a high potential for the production of biodiesel and high value products. The group recommends that DOST explore the possibility of adopting this technology in the country for the production of terpenoid derived high value products which may find applications in the flavor, cosmetic, personal care and scent

In view of the continuing collaboration of the DOST-BC and the Bureau of Plant Industry (BPI) in providing technical guidance on activities involving contained use of genetically modified organism, a workshop was conducted on 10-12 October 2015 in Baguio City.

The workshop was conducted to harmonize monitoring protocols as regards the ongoing projects under contained use, specifically on confined test. Participants representing each agencies had discussed issues and concerns on the current monitoring system such as the functions and powers of the monitoring team on-site; monitoring forms; Public Information Sheet (PIS); and the delineation of DOST-BC and DA-BPI field testing.

The workshop was concluded with the following agreements: On monitoring activities, a checklist for monitoring will be drafted on a per-project and per-activity basis; any agreements made during the DOST BC meetings shall be communicated to the monitors; the monitors should exercise their power to stop any activity if there is non-compliance with the confined test conditions such as absence of IBC representative. The group agreed to schedule another workshop to review and harmonize the forms currently being used by DOST-BC and BPI. The aim was to come up with common monitoring forms which will include both concerns on biosafety and quarantine. This will streamline the monitoring and reporting process of teams deployed in the field. It was further agreed that the BPI will harmonize the process of posting its PIS with

the DOST-BC guidelines. On the delineation of DOST-BC confined test and BPI field trial, BPI was requested to come up with official guidelines that will differentiate both testing in relation to area, isolation distance, confinement measures, and line selection, among others. The DOST-BC and BPI-BCT Secretariats were also tasked to research on isolation distances for various crops as a preliminary information for the isolation requirements that will be formulated.

The group also managed to review the risk assessment report (RAR) form currently being used. Modifications were discussed to evaluate the applicability of the forms in assessing future GM traits. Examples of new GM traits which might be applied in the future includes stress tolerant (drought and salt), nitrogen-use efficient, nutrient altered, pharm crops, insect resistant and herbicide tolerant, among others.

Since it was agreed that one RAR form will not be applicable to all applications, it was suggested to have a lead for each aforementioned trait. The lead with the guidance from BPI’s Scientific and Technical Review Panel (STRP) will be responsible in formulating possible additional questions in the RAR form for new applications. The group agreed to retain the current RAR forms but will add questions depending on the type of application, when necessary.

These agreements were expected to be implemented in 2016.

DOST-BC, BPI conduct workshop on contained use monitoring

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8DOST-BC publishes contained use guidelines and circularsThe DOST-BC released two guidelines in January 2015 entitled, The Philippines Biosafety Guidelines for Contained Use of Genetically Modified Organisms (GMOs), revised edition, and The Philippines Biosafety Guidelines and Procedures for Containment of Transgenic Arthropods.

The Guidelines contains procedures for application and monitoring of contained use and confined tests of GMOs, including transgenic arthropods. Also contained in both manuals were the specific functions of the DOST -BC, the Institutional Biosafety Committee, the Proponents and other agencies involved to facilitate the process of ensuring that the GMOs under study posed no or minimum risks to the environment, animal and human health.

The manual further specifies the required level of containment of any particular activity, packaging and transport of regulated materials. It lists the basic instructions, monitoring and appropriate measures in cases of incidents resulting from the use of GMOs. Forms required in the preparation of proposals and assessments, and in compliance with reportorial requirements were also included.

A number of experts from different fields of science was tapped to draft and finalize both manuals. The document is considered a work-in-progress as it continues to develop along-side the changing needs and circumstances brought by the rapid advances in modern biotechnology.

The Manuals were approved in September and October 2014, respectively, and published in January 2015.

In addition to the said guidelines, the DOST-BC also released the following Circulars to supplement the provisions of the manuals:

• On implementation of approved projects• Amendments on Posting of Project

Information Sheet for Purposes of Public Notification and Comment

• On transplanting activity of approved confined test

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9ANNEX IList of DOST-BC Ongoing ProjectsUP Los Baños

No. Title2008-0227 Development of Regeneration System for Biolistic-mediated Transformation for Abaca (Musa

textilis Nee) Resistant to Abaca Bunchy Top Virus (ABTV) 2008-0233 Development and Commercialization of Fruit and Shoot Borer-Resistant Bt Eggplant:

Generation Advancement of Backcross Selections with MAHYCO Transformation Event EE-1 and Development of Experimental Hybrids

2009-0237 Contained Trial of Selected PRSV-CP Papaya Plants from Candidate Events E-124 and 132 for Further Breeding and Event Selection, Virus Resistance Testing and Molecular Characterization

2009-0243 Contained trial in BL2 Greenhouse for event selection of PRSV-CP Transformation Events (-49, -125, -128, -135, -142, -143, -144, -146, -148, -149, -153, -156, -157, -158, -159, -162 and -164) generated under NCBP Ref No. 2001-0152 (former title: Bioefficacy Testing and Molecular Analyses of Other Events Derived from PRSV-CP Construct”)

2011-0259 Generation Advance in BL2 Screenhouse and Progeny Screening in BL2 Greenhouse for PRSV Resistance of Selected Transgenic Papaya Plants Generated under NCBP Ref. Nos. 2009-0237 and 2009-0243

2012-0270 Biotechnology-Assisted Development of Virus-Resistant Varieties and Populations of Squash for Climate Change Adaptation

2012-0271 Genetic Diversity of the Philippine Tomato Leaf Curl Virus (ToLCV-P) and Development of Infectious cDNA Clone for ToLCV Resistance Screening in Tomato

2015-0289 Overexpression, Purification and Characterization of a Recombinant Thermo-stable Endoglucanase for Effective Hydrolosis of Lignocellolosic Materials

UP Diliman

No. Title2008-0228 Molecular Characterization of Abaca Bunchy Top Virus (ABTV), Development of Viral Gene

Constructs and Transformation of Selected Abaca Cultivars 2012-0267 Cloning and expression of the Plasmodium falciparum MSP-1 block 2 gene and biochemical

characterization of its gene product

UP Mindanao

No. Title2012-0269 Cloning and Expression of Raw Starch Digesting-Amylase Genes from Saccharomycopsis

Fibuligeria and Saccharomycopsis Bubodii for Direct Ethanol Fermentation

SYNGENTA PHILIPPINES, INC.

No. Title2011-0265 Screenhouse Trial on Conversion of Regulated Event MIR162 into the Syngenta Developed Line

PHILRICE

No. Title2015-0290 Production of Plant Materials for Compositional Analysis and for other Biosafety Tests of Golden

Rice event GR2-E under Confined Test Conditions in the Philippines (PhilRice-Batac)2015-0291 Production of Plant Materials for Compositional Analysis and for other Biosafety Tests of Golden

Rice event GR2-E under Confined Test Conditions in the Philippines (PhilRice-CES Proposal)2015-0292 Production of Plant Materials for Compositional Analysis and for other Biosafety Tests of

Golden Rice event GR2-E under Confined Test Conditions in the Philippines (PhilRice-Isabela Proposal)

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International Rice Research Institute

No. Title2008-0230 Effect of Bt transgene flow on lepidopteran-based food webs 2008-0232 Production of IR64 transgenic rice using HD Zip genes for drought tolerance and evaluation of

Rojolele rice cultivar harboring Oshox-4 gene 2009-0239 Production and evaluation of transgenic rice using candidate genes for C4 photosynthesis 2009-0244 Identify C₄ness in rice activation mutants 2009-0246 Development of transgenic rice tolerant to drought using set of new gene constructs

(continuation/amended NCBP 20050201 entitled "Devt of Transgenic Rice Tolerant to Drought")2011-0253 Validation of candidate genes through transformation for tolerance to anaerobic germination

in rice 2011-0255 Validation on the involvement of a translation initiation factor 4G for resistance to rice tungro

spherical virus in transgenic rice plants 2011-0256 Evaluation of transgenic rice lines expressing the pea albumin PA1 for resistance to Brown

planthopper, White-backed planthoppers, Green leafhopper, Stemborer and the Asian rice bug

2011-0258 Improving transgene integration and expression in indica rice by site-specific targeting and homologous recombination

2011-0260 Evaluation of insertion lines of rice under Confined Field Test conditions for morphological and agronomic traits related to C4ness

2011-0261 Evaluation of Candidate Genes for Heat and Drought Tolerance in Rice2011-0262 Evaluation of tDNA insertion lines of rice from Colombia, Australia and France under Confined

Field Test conditions for morphological and agronomic traits related to C4ness 2011-0263 Evaluation of insertion lines of rice from Taiwan, Korea and Japan under Confined Field Test

conditions for morphological and agronomic traits related to C4ness 2012-0266 Confined Field Trial on Evaluation of IR64 Transgenic Lines for Drought Tolerance III2013-0272 Silencing and over-expression of C4 photosynthetic genes in Green Foxtail (Setaria viridis, Acc.

No. A10.1) 2013-0273 Characterization of a rice root suberin mutant in response to drought stress 2013-0274 Investigation of genetic components of non-race-specific resistance to blast disease and

bacterial blight in rice 2014-0279 Identification of transcription activator-like (TAL) effector-mediated resistance genes to

Xanthomonas oryzae pv oryzae in a set of broad spectrum rice varieties 2014-0280 Gene Transfer System using Replicons for Targeted Plant Genome Engineering2014-0281 Enhancing iron content in rice grains using plant Fe-hemostasis genes 2014-0282 Confined Field Trial of Iron Biofortified Transgenic Rice (Part 3) 2014-0283 Gene validation for high-value agronomic QTLs in rice 2014-0284 Breeding Research of Pro-Vitamin A Enriched ‘Golden Rice’ Event GR2-E Introgressed Lines

Under Confined Field Test Condition” 2014-0285 Functional characterization of rice lines carrying the wheat durable broad-spectrum resistance

gene Lr34 2015-0286 Evaluation of Pro-vitamin A enriched 'Golden Rice' Event GR2-E introgressed lines of PSB Rc82

under confined field test condition2015-0287 Targeted mutagenesis in the promoter region of sugar transporter genes in rice2015-0288 Localization and expression studies of rice non-symbiotic hemoglobins through a GUS promoter

reporter gene system to understand their role in tolerance of anaerobic conditions caused by different kind of floods

2015-0293 Production of Plant Materials for Compositional Analysis and other Biosafety Tests of Golden Rice event GR2-E under Confined Test Conditions in the Philippines (IRRI proposal)

2015-0294 Validation of function of genes associated with C4 photosynthesis and other related traits through CRISPR/Cas9 System

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Department of science and technology-BIOSAFETY COMMITTEE (DOST-BC)

Dr. Jaime C. Montoya Chairman

Dr. Dolores A. Ramirez Biological Scientist

Dr. Flerida A. Cariño Physical Scientist

Jose Maria A. Ochave, Esq. Social Scientist / Legal Adviser

Dr. Preciosa Corazon Pabroa Environmental Scientist

Assistant Secretary Paz J. Benavidez ii DA Representative

Ms. Merle B. Palacpac Official Alternate of ASEC. Paz J. Benavidez

Dr. Henry A. Adornado DENR representative

Ms. Veronica O. Sinohin Official Alternate of Dr. Henry A. Adornado

Dr. Oscar G. Gutierrez, Jr. DOH representative

Dr. Leonardo A. Gonzales Community Representative

Ms. Hermelina C. Tenorio Community Representative

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THE SECRETARIAT

Ms. Julieta Fe L. EstacioHead Secretariat

Ms. Katherine E. SorianoSupervising Science Research Specialist

Ms. Elaine Mae L. Soriano Senior Science Research Specialist

Ms. Claudine Kristia B. Pascual Science Research Specialist ii

Mr. Francefe C. Pacis Computer Operator iv

Mr. Richard A. Purisima(Former) Project Assistant iv

Mr. Raphael B. PalacpacScience Research Specialist i

Mr. Jay-ar J. BañadosScience Research Analyst

Department of Science and TechnologyRm. 305, 3/F Dost Bldg. General Santos Ave., Bicutan, Taguig City

Tel: (632) 837-2071 to 82 local 2012Fax tel: 632-837-2943

Email: ncbpsecretariat@gmail.com

Websites:Dost-bc: http://dost-bc.dost.gov.ph

Ncbp: www.ncbp.dost.gov.phBch: http://bch.dost.gov.ph