MAY 22, 2006 OFFICIAL GAZETTE 3295

MALACANANGMANILA

EXECUTIVE ORDER No. 514

ESTABLISHING THE NATIONAL BIOSAFETYFRAMEWORK, PRESCRIBING GUIDELINES FORITS IMPLEMENTATION, STRENGTHENING THENATIONAL COMMITTEE ON BIOSAFETY'OF THEPHILIPPINES, AND FOR OTHER PURPOSES

WHEREAS, there is rapid expansion of the useof modem biotechnology not only for scientificresearch but also for products for commercialreleases and purposes;

WHEREAS, there is concern over modembiotechnology's potential impacts on theenvironment, particularly on biologicaldiversity, on human health, and on social andcultural well-being;

WHEREAS, it is the policy of the State topromote the safe and responsible use of modembiotechnology and its products as one of theseveral means to achieve and sustain foodsecurity, equitable access to health services,sustainable and safe environment and industrydevelopment;

WHEREAS, the Cartagena Protocol onBiosafety to the United Nations Convention onBiological Diversity which the Philippinessigned on 24 May 2000 entered into force on11 September 2003;

WHEREAS, the National Committee onBiosafety of the Philippines (NCBP),Department of Science and Technology,Department of Agriculture, Department ofHealth, and Department of Environment andNatural Resources have played, since 1987, apioneering and important role in developing andestablishing the current biosafety system;

WHEREAS, there is a need to enhance theexisting biosafety framework to better respondto the challe~ges presented by further advances

in modem biotechnology and to comply withthe administrative requirements of the CartagenaProtocol on Biosafety;

Now, THEREFORE, I, GLORIA MACAPAGAL­ARROYO, President of the Philippines, by virtueof the powers vested in me by law, do herebyorder:

SECTION 1. Adoption and Operationalizationof the National Biosafety Framework.-TheNational Biosafety Framework (NBF) for thePhilippines, attached hereto as Annex A, ishereby adopted.

SEC. 2. Scope and Objectives.-The NBFshall have the following scope and objectives:

2.1 Scope. The NBF shall apply to thedevelopment, adoption and imple­mentation of all biosafety policies,measures and guidelines and in makingbiosafety decisions concerning theresearch, development handling and use,transboundary movement, release into theenvironment and management ofregulated articles.

2.2 Objectives. The NBF shall have thefollowing objectives:

2.2.1 Strengthen the existmg science­based determination of biosafetyto ensure the safe and responsibleuse of modem biotechnology sothat the Philippines and its citizenscan benefit from its applicationwhile avoiding or minimizing therisks associated with it;

2.2.2. Enhance the decision-makingsystem on the application ofproducts of modem biotechnologyto make it more efficient,predictable, effective, balanced,culturally appropriate, ethical,transparent and participatory; and

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2.3.3. Serve as guidelines forimplementing internationalobligations on biosafety.

SEC. 3. Administrative Framework andDecision-Making Processes.-In makingbiosafety decisions, the administrative systemand decision-making processes established inthe NBF shall be complied with.

SEC. 4. Strengthening the National Committeeon Biosafety of the Philippines (NCBP).-TheNCBP is hereby strengthened. Its mandate,functions, composition and organization are set .forth in the NBF.

SEC. 5. General Mandate on Departments,Offices and Agencies.-The mandates,jurisdictions and other powers of all departmentsand agencies in relation to biosafety andbiotechnology shall be guided by the NBF andcoordinated with the NCBP and each other inexercising such powers.

SEC. 6. Funding.-The DOST, DENR, DA,and DOH shall allocate funds from their presentbudgets to implement the NBF, includingsupport to the operations of the NCBP and itsSecretariat. Starting 2006 and thereafter, thefunding requirements shall be included in theGeneral Appropriations Bill submitted by eachof said departments to Congress.

These concerned departments shall enter intoagreement on the sharing of financial andtechnical resources to support the NCBP andits Secretariat.

SEC. 7. Transition.-The NCBP and itspresent members shall continue to exercise theirpresent functions under Executive Order No.430, s; 1990 until such time that it hascompletely reorganized under the NBF. The

reorganization shall commence immediatelyafter the DOST, DENR, DA, and DOH haveentered into an agreement on the sharing offinancial and technical resources to.support theNCBP and its Secretariat on a sustainable basis,and shall be completed within one year fromeffective date of such agreement.

All members of the NCBP to be appointedby the President, as required by the NBF, shallassume their positions upon completion of thereorganization.

SEC. 8. Repealing and Amending Clause.­All orders, rules and regulations or parts theretowhich are inconsistent with any of the provisionsof this Order are hereby repealed or amendedaccordingly. For the avoidance of doubt, thefollowing issuances, unless amended by therespective issuing departments or agencies, shallcontinue to be in force and effect: Departmentof Agriculture Administrative Order No. 008,s. 2002; the NCBP Guidelines on the ContainedUse of Genetically Modified Organisms, exceptfor provisions on potentially harmful exoticspecies which are hereby repealed; and allBureau of Food and Drugs issuances on productsof modem biotechnology.

SEC. 9. Effectivity.-This Order shall takeeffect fifteen days after publication in twonewspapers of general circulation.

DONE in the City of Manila, this 17th day ofMarch in the year of Our Lord Two Thousandand Six.

(Sgd.) GLORIA MACAPAGAL-ARROYOPresident of the Philippines

By the President:

(Sgd.) EDUARDO R. ERMITAExecutive Secretary

MAY 22,2006 OFFICIAL GAZETTE 3297

NATIONAL BIOSAFETY FRAMEWORKFOR THE PHILIPPINES

SECTION 1. CONSTITUTIONAL POLICIES

In implementing the National BiosafetyFramework (NBF), the following state policiesmandated by the 1987 Constitution shall guidethe concerned government department andagencies:

1.1 Right to Health.-The State shallprotect and promote the right to healthof the people and instill healthconsciousness among them (Article II,Section 15);

1.2 Right to a Healthy Environment.-TheState shall protect and advance the rightof the people to a balanced and healthfulecology in accord with the rhythm andharmony of nature (Article II, Section16).

1.3 Priority to Science.-The State shallgive priority to education, science andtechnology, arts, culture, and sports tofoster patriotism and nationalism,accelerate social progress, and promotetotal human liberation and development(Article II, Section17);

1.4 Role of the Private Sector.-The Staterecognizes the indispensable role of theprivate sector, encourages privateenterprise, and provides incentivesto needed investments (Article II,Section 20);

1.5 Rural Development.-The State shallpromote comprehensive ruraldevelopment and agrarian reform(Article II, Section 21) and shall providesupport to agriculture throughappropriate technology and research,and adequate financial, production,marketing, and other support services(Articles XIII, Section 5)j

1.6 Right of Indigenous Peoples andCommunities.-The State recognizesand promotes the rights of indigenouscultural communities within theframework of national unity anddevelopment (Article II, Section 22).The State, subject to the provisions ofthis Constitution and nationaldevelopment policies and programs,shall protect the rights of indigenouscultural communities to their ancestrallands to ensure their economic, social,and cultural well-being (Article XIII,Section 5);

1.7 Right to Information.-Subject toreasonable conditions prescribedby law,the State adopts and implements apolicy of full disclosure of all itstransactions involving public interest(Article II, Section 28);

1.8 Local Autonomy.-The territorial andpolitical subdivisions shall enjoy localautonomy (Article 10, Section 2);

1.9 Right to Participation.-The right ofthe people and their organizations toeffective and reasonable participation atall levels of social, political, andeconomic decision-making shall not beabridged. The State shall, by law,facilitate the establishment of adequateconsultation mechanisms (Article XIII,Section 16);

1.10 Science and Technology.-Science andtechnology are essential for nationaldevelopment and progress. The Stateshall give priority to research anddevelopment, invention, innovation, andtheir utilization; and to science andtechnology education, training, andservices. It shall support indigenous,appropriate, and self-reliant scientificand technological capabilities, and theirapplication to the country's productive

3298 OFFICIAL GAZETTE VOL. 102, No. 21

systems and national life. The Stateshall regulate the transfer and promotethe adaptation of technology from allsources for the national benefit. It shallencourage the widest participation ofprivate groups, local governments, andcommunity-based organizations in thegeneration and utilization of science andtechnology (Article XIV, Sections 10and 12), and,

1.11 Consumer Protection-s-The State shallprotect consumers from trademalpractice and substandard andhazardous products (Article XVI,Section 9).

SEC. 2. PRINCIPLES

The following principles, based on nationaland international law, shall apply in a mutuallysupportive manner to the implementation of theNBF:

2.1 Policy on Modern Biotechnology.­The NBF shall be implemented in thecontext of the overall policy of thePhilippines on modem biotechnology,to wit: The State shall promote the safeand responsible use of modernbiotechnology and its products as oneof the several means to achieve andsustain food security, equitable accessto health services, sustainable and safeenvironment and industry development;

2.2 Policy on Sustainable Development.­The overall policy of the Philippines onsustainable development, as laid downin Philippine Agenda 21, shall equallyguide the implementation of the NBF:

2.3 A Balanced Approach.-A balanceapproach, which recognizes both thepotential benefits ad risks, shall guidethe implementation of the NBF. Thisshall be based on recognition that

modem biotechnology has significantpotential for human well-being ifdeveloped and used with adequate safetymeasures for the environment andhuman health. Such approachrecognizes both the potential benefitsand risks of modem biotechnology tohuman health, agricultural productivity,food security, the livelihoods of thepoor, biological diversity and theenvironment;

2.4 A Scientific Approach.-Theimplementation of the NBF shall bebased on the best available science andknowledge. Such science andknowledge shall be of the highestquality, multi-disciplinary, peer­reviewed, and consistent withinternational standards as they evolve;

2.5 Socio-economic, Cultural, and EthicalConsiderations.-The socio-economic,ethical, and cultural benefits and risks,of modern biotechnology to thePhilippines and its citizens, and inparticular on small farmers, indigenouspeoples, women, small and mediumenterprises and the domestic scientificcommunity, shall be taken into accountin implementing the NBF;

2.6 Using Precaution.-In accordance withPrinciple 15 of the Rio Declaration of1992 and the relevant provisions of theCartagena Protocol on Biosafety, inparticular Articles 1, 10 (par. 6) and11 (par. 8), the precautionary approachshall guide biosafety decisions. Theprinciples and elements of this approachare hereby implemented through thedecision-making system in the NBF;

2.7 Transparency and PublicParticipation.-Decision taken underthe NBF shall be arrived at in atransparent and participatory manner.

MAY 22, 2006 OFFICIAL GAZETTE 3299

Biosafety issues are best handled withthe participation of all relevantstakeholders and organizations. Theyshall have appropriate access toinformation and the opportunity toparticipate responsibly and inaccountable manner in biosafetydecision-making processes.

2.8 Consensus Building.-In makingbiosafety decisions, all concernedgovernment departments and agenciesshall exert all efforts to find consensusamong all relevant stakeholders usingwell-accepted methods such asnegotiation, mediation, and otherappropriate dispute resolution processes.Such consensus, to be achieved in atransparent and participatory manner,shall be based on the best availablescience and knowledge and shall notcompromise public safety and welfare;

2.9 PrincipleofSubsidiarity.-As providedby law and where competence exists,all levels of government, includinglocal government units, shall participatein implementing the NBF;

2.10 Availability of Remedies.-Effectiveaccess to judicial and administrativeproceedings, including redress andremedy, shall be available in accordancewith Philippine law;

2.11 International Obligations andCooperation.-In accordance withinternational law, the NBF shall beimplemented in a manner consistentwith and mutually supportive of theinternational obligations of thePhilippines, in particular its ooligationsunder international trade andenvironmental law. Multilateral,regional and bilateral cooperation inimplementing the NBF, in particular itssections on capacity building andfinancial resources, shall be encouraged;

2.12.Efficient Administration and TimelyDecision Making.-The NBF decisionmaking process shall be conducted inan efficient, coordinated, effective,predictable, cost-effective and timelymanner. Undue delay shall be avoidedwithout compromising transparency,public participation, public safety, andpublic welfare; and

2.13 Public interest and welfare.-In cases'of conflict in applying these principles,the principle of protecting public interestand welfare shall always prevail. Nosection or provision in this Frameworkshall be construed as to limit the legalauthority and mandate of heads ofdepartments and agencies to considerthe national interest and public welfarein making biosafety decisions.

SEC. 3. SCOPE, OBJECTIVES ANDDEFINITIONS

3.1 Scope.-The NBF shall apply tothe development, adoption andimplementation of all biosafety policies,measures and guidelines and in makingdecisions concerning the research

.development, handling and use,transboundary movement, release intothe environment and management ofregulated articles.

3.2. Objectives.-The NBF shall have thefollowing objectives:

3.2.1 Strengthen the existing science­based determination of biosafetyto ensure the safe and responsibleuse of modem biotechnology sothat the Philippines and itscitizens can benefit from itsapplication while avoiding orminimizing the risks associatedwith it;

3300 OFFICIAL GAZETTE VOL. 102, No. 21

3.2.2 Enhance the decision-makingsystem on the applicationof products of modernbiotechnology to make it moreefficient, predictable, effective,balanced, culturally-appropriate,ethical, transparent andparticipatory; and,

3.2.3 Serve as guidelines forimplementing internationalobligations on biosafety.

3.3 Dejinitions.-For purposes of thisframework, the following terms shallmean:

3.3.1 "Biosafety" is a condition inwhich the probability of harm,injury and damage resulting fromthe intentional and unintentionalintroduction and/or use of aregulated article is withinacceptable and manageablelevels;

3.3.2 "Biosafety Clearing house" is aninformation exchange mechanismestablished by the CartagenaProtocol on Biosafety to assistparties in the implementation ofits provisions and to facilitatesharing and exchange ofscientific, technical, environ­mental and legal information on,and experience with, regulatedarticles;

3.3.3 "Biosafety decision" apply to thedevelopment, adoption andimplementation of all biosafetypolicies, measures and guidelinesand in making decisionsconcerning the research,development, handling and use,transboundary movement, releaseinto the environment andmanagement of regulated articles;

3.3.4 "Contained use" means anyoperation, undertaken within afacility, installation or otherphysical structure, whichinvolves genetically modifiedorganisms that are controlled byspecific measures that effectivelylimit their contact with, andtheir impact on, the externalenvironment;

3.3.5 "Genetically modifiedorganisms" also refers to "livingmodified organism" under theCartegena Protocol on Biosafetyand refers to any living organismthat possesses a novelcombination of genetic materialobtained through the use ofmodern biotechnology;

3.3.6 "Handling and Use" means theprocess by which regulatedarticles are moved, carried,transported, delivered, stored orworked with;

3.3.7 "Hazard" refers to traits inherentto or activities of a regulatedarticle that may cause harm tohuman or animal health or to theenvironment;

3.3.8 "Management" means measuresadopted after the release ofregulated articles to ensure theirsafe use and, in cases ofcommercial release, shall alsoinclude product monitoring andproduct identification;

3.3.9 "Modern biotechnology" meansthe application of: a) in vitronucleic acid techniques, includingrecombinant deoxyribonucleicacid (DNA) or direct injection ofnucleic acid into cells or

MAY 22, 2006 OFFICIAL GAZETTE 3301

organelles; or b) fusion of cellsbeyond the taxonomic family,that overcome naturalphysiological reproductive orrecombination barriers and thatare not techniques used intraditional breeding or selection;

3.3.10 "Product Identification" refers toinformation on the presence of aregulated article in a particularproduct, as implemented byconcerned departments andagencies through import andexport documents, uniqueidentification system, or similarapplicable approaches such asproduct labeling;

3.3.11 "Product Monitoring" refers toany post-commercializationmeasure that provides data on thefate and effects of the regulatedarticle, in order to confirmcompliance with regulatoryrequirements, collect informationnecessary for controlling andmanaging potentially adversepublic health or environmentalsituations, assess environmentalquality and detect unexpected orpotentially damaging effects onhuman and animal health and theenvironment. Product monitoringhelps reduce uncertaintyremaining from risk assessment,confirm conclusions withadditional data and provideinformational feedback on systemstatus or conditions;

3.3.12 "Regulated article" refers to agenetically modified organismand its products;

3.3.13 "Risk" refers to the combinationof the likelihood that an adverse

consequence of a biohazardousactivity or trait will occur andthe magnitude of such aconsequence;

3.3.14 "Risk assessment" refers to theprocedure that identifies,evaluates and predicts theoccurrence of possible hazards tohuman and animal health and theenvironment and designsmitigating measures to avert orminimize these hazards;

3.3.15 "Risk management" refers toappropriate mechanisms,measures and strategies toregulate, manage and controlrisks identified in the riskassessment including thoseconditions imposed by concerneddepartments or agencies;

3.3.16 "Transboundary movement"means .the movement of aregulated article from anothercountry to the Philippines andfrom the Philippines to anothercountry; and

3.3.17 "Transformation event" meansone instance of 'entry, stableintegration and expression of anintroduced gene into a cell whichthen develops into a functionalorganism expressing theintroduced gene.

SEC. 4. ADMINISTRATIVEFRAMEWORK

The administrative mechanism for biosafetydecisions shall be as follows:

(a) National scientific and technical biosafetystandards and standards on methods andprocedures for ensuring biosafety in the

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country, shall be set by the NCBP consistent 4.2 Composition of the NCBP.-The NCBPwith existing laws; shall be composed of the following:

(b) Basic policies on addressing public interestson biosafety shall be developed by theNCBP, provided the same are consistentwith law and if such policies are foundinsufficiently addressed in existing mandatesand regulations of pertinent agencies;

(c) Member-agencies of the NCBP shallcontinue to perform their regulatoryfunctions in accordance with their legalmandates, provided that their policies andprograms relating to biosafety shall bediscussed in the NCBP for purposes ofharmonization with other agencies'functions;

(d) Other concerned agencies shall coordinatewith NCBP on matters that may affectbiosafety decisions as provided in Section4.7 to 4.14;

(e) Administrative functions required under theCartagena Protocol on Biosafety shall beperformed by agencies as provided inSection 4.14 and 4.15; and

(f) The role stakeholders and the general publicshall be recognized and taken into accountas provided in Sections 6 and 7.

4.1 Mandate of the National Committee onBiosafety ofthe Philippines (NCBP).-TheNCBP shall be the lead body to coordinateand harmonize inter-agency and multi-sectorefforts to develop biosafety policies in thecountry (where such are not alreadystipulated by law) and set scientific,technical and procedural standards onactions by agencies and other sectors topromote biosafety in the Philippines;oversee the implementation of the NBF; actas a clearing house for biosafety matters;and coordinate and harmonize the effortsof all concerned agencies and departmentsin this regard.

4.2.1. The Secretaries of the Departmentsof Science and Technology,Agriculture, Health, Environment andNatural Resources, Foreign Affairs.Trade and Industry, and Interior andLocal Governments or theirdesignated representatives. TheDOST Secretary shall be thepermanent Chair;

4.2.2 A consumer representative appointedby the President from a list submittedby nationally recognized consumerorganizations, serving for a term ofthree (3) years, renewable for anotherterm;

4.2.3 A community representative from thefarmers, fisherfolk and indigenoussector appointed by the Presidentfrom a list submitted by nationallyrecognized sectoral organizations,serving for a term of three (3) years,renewable for another term;

4.2.4 A representative from industryappointed by the President from a listsubmitted by the Secretary of Tradeand Industry, serving for a term ofthree (3) years, renewable for anotherterm; and,

4.2.5 A biological scientist, physicalscientist, environmental scientist,health scientist, and social scientistto be endorsed by the DOSTSecretary upon the recommendationof recognized professional andcollegial bodies such as the NationalAcademy of Science and Technology(NAST) and the Philippine SocialScience Council (PSSC), andappointed by the President, eachserving for a term of three (3) years,renewable for another term.

MAY 22, 2006 OFFICIAL GAZETTE 3303

4.6.2 Accountability Functions

periodically reviewing theNBF;

4.6.2.1 Monitor the Implementationof the NBF by concerneddepartments and agencies;

4.6.2.2 Ensure coordination amongcompetent nationalauthorities that have sharedmandates;

Congressappropriate

Propose tonecessary andlegislation.

4.6.1.6

4.6.1.5 Issue detailed guidelines onthe conduct of socio­economic impact evaluationof biosafety decisions; and,

4.6 Powers and Functions of the NCBP.-Asthe lead body in implementing the NBF,the NCBP shall have the following powersand functions:

4.6.1 Biosefety Policy Functions

4.5 NCBP Secretariat.-The NCBP shall createa Secretariat that shall be based in theDOST. All other concerned agencies maybe called upon to participate in the functionsof the Secretariat.

4.4 Meetings of the NCBP.-The NCBP shallmeet regularly as it deems fit and shallformulate its standards for making decisions.

4.3 NCBP Executive Committeeand TechnicalWorking Groups.-The NCBP may createan Executive Committee and TechnicalWorking Groups as it deems necessary andappropriate.

4.6.1.1 Assist concerneddepartments and agencies informulating, reviewing, oramending their respectivepolicies, measures andguidelines on biosafety;

4.6.1.2 Hold public deliberations onproposed national policies,guidelines, and otherbiosafety issues;

4.6.1.3 Provide assistance in theformulation, amendment ofpertinent laws, rules andregulations;

4.6.1.4 In coordination withconcerned departments andagencies and consistent withthe requirements oftransparency and publicparticipation as provided inSection 6 and 7 of the NBF,shall take the lead in

4.6.2.3 Ensure that NCBPguidelines, and theprinciples and processesestablished in thisFramework are compliedwith the concerneddepartments and agencies;and,

4.6.2.4 Review procedures foraccountability in biosafetydecision-making bycompetent nationalauthorities, with particularemphasis on ensuringindependence andimpartiality In suchdecisions.

4.6.3 Scientific Functions

4.6.3.1 Facilitate the study andevaluation of biosafetyresearch and control andminimize the concomitant

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risks and hazards associatedwith the deliberate releaseof regulated articles in theenvironment;

4.6.3.2 Identify and evaluatepotential hazards involvedin modem biotechnologicalexperiments or theintroduction of regulatedarticles and recommendmeasures to minimize risks;

4.6.3.3 Recommend thedevelopment and promotionof research programs toestablish risk assessmentprotocols and assessment oflong-term environmentaleffects of regulated articles;

4.6.3.4 Develop workingarrangements with thegovernment quarantineservices and institutions inthe evaluation, monitoring,and review of projects vis­a-vis adherence to nationalpolicies and guidelines onbiosafety;

4.6.3.5 Review and developguidelines in the riskassessment of regulatedarticles for contained use;

4.6.3.6 Assist other agencies indeveloping risk assessmentguidelines and proceduresof regulated articles for fieldtrials and commercialrelease;

4.6.3.7 Review the appointment ofthe members of theinstitutional BiosafetyCommittees created by

institutions engaged inactivities involvingregulated articles, uponrecommendation by theirrespective heads of·institutions;

4.6.3.8 Publish the results ofinternal deliberations andagency reviews of theNCBP;

4.6.3.9 Hold discussions on thecomparative ecological,economic and socialimpacts of alternativeapproaches to attain thepurposes/objectives ofthe proposed geneticmodification products and!or services; and,

4.6.3.10 Perform such functions asmay be requested byconcerned departments andagencies.

4.6.4 Capacity Building Functions

4.6.4.1 Assist in the developmentof technical expertise,facilities, and otherresources for quarantineservices and riskassessments; and,

4.6.4.2 Take the lead in developingand implementing a nationalcapacity-building programfor biosafety.

4.7 Mandate of the Department of Scienceand Technology.-The Department ofScience and Technology (DOST), as thepremiere science and technology body inthe country, shall take the lead in ensuringthat the best available science is utilized

MAY 22, 2006 OFFICIAL GAZETTE 3305

and applied in adopting biosafety policies,measures and guidelines, and in makingbiosafety decisions. The DOST shallensure that such policies, measures,guidelines and decisions are made on thebasis of scientific information that is ofthe highest quality, multi-disciplinary,peer-reviewed, and consistent withinternational standards as they evolve. Incoordination with other concerneddepartments and agencies, and consistentwith the requirements of transparency andpublic participation as provided in Sections6 and 7 of the NBF, it shall exercise suchjurisdiction and other powers that it hasbeen conferred with under existing laws.It shall also take the lead in evaluatingand monitoring regulated articles intendedfor contained use.

4.8 Mandate of the Department ofAgriculture.-As the principal agency ofthe Philippine government responsible forthe promotion of agricultural developmentgrowth, rural development so as to ensurefood security and contribute to povertyalleviation, the Department of Agricultureshall take the lead in addressing biosafetyissues related to the country's agriculturalproductivity and food security. Incoordination with other concerneddepartments and agencies, and consistentwith the requirements of transparency andpublic participation as provided in Section6 to 7 of the NBF, it shall exercise suchjurisdiction and other powers that it hasbeen conferred with under existing laws.It shall also take the lead in evaluatingand monitoring plant and plant productsderived from the use of modernbiotechnology, as provided in Departmentof Agriculture Administrative Order No.008, s. 2002.

4.9 Mandate of the Department ofEnvironment and Natural Resources.­As the primary government agency

responsible for the conservation,management, development and proper useof the country's environment and naturalresources, the Department of Environmentand Natural Resources (DENR) shallensure that environmental assessments aredone and impacts identified in biosafetydecisions. It shall also take the lead inevaluating and monitoring regulatedarticles intended for bioremediation, theimprovement of forest genetic resources,and wildlife genetic resources.

4.10 Mandate of the Department of Health.­The Department of Health (DOH), as theprincipal authority on health, shallformulate guidelines in assessing the healthimpacts posed by modem biotechnologyand its applications. The DOH shall alsorequire, review and evaluate results ofenvironmental health impact assessmentsrelated to modem biotechnology and itsapplications. In coordination with otherconcerned departments and agencies, itshall exercise such jurisdiction and otherpowers that it has been conferred withunder existing laws. It shall also take thelead in evaluating and monitoringprocessed food derived from or containinggenetically modified organisms.

4.11 Mandate of Associated Departments andAgencies.-In coordination with otherconcerned departments and agencies, andconsistent with the requirements oftransparency and public participation asprovided in Sections 6 to 7 of the NBF,

. all other departments and agencies shallexercise such jurisdiction and other powersthat it has been conferred with underexisting laws. In particular, the followingdepartments and agencies shall participatein biosafety decision making, whereappropriate: the Department of ForeignAffairs in promoting and protectingPhilippine interests on biosafety inbilateral, regional and multilateral forums;

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the Department of Trade and Industry inrelation to biosafety decisions which havean impact on trade, intellectual propertyrights, investments and consumer welfareand protection; the National Commissionon indigenous Peoples in relation tobiosafety decisions which have a specificimpact on indigenous peoples andcommunities; and the Department ofInterior and Local Government, in relationto biosafety decisions which have animpact on the autonomy of localgovernment units.

4.12 Focal Point and Competent NationalAuthorities.

4.12.1 For purposes of Article 19 of theCartagena Protocol on Biosafety,the national focal point responsiblefor liaison with the Secretariatshall be the Department of ForeignAffairs. The competent nationalauthorities, responsible forperforming the administrativefunctions required by the Protocol,shall be, depending on theparticular genetically modifiedorganisms in questions, thefollowing:

4.12.1.1 The Department of Agri­culture, for biosafetydecisions, when coveredby the Protocol, concern­ing plants and plantproducts derived frommodern biotechnology,fisheries and otheraquatic resources, domes­ticated animals andbiological productsused for animal hus­bandry or veterinary pur­poses and biologicalagents used forbiocontrol;

4.12.1.2 The Department ofScience and Technology,for biosafety decisions

concerning researchand development, whencovered by the Protocol;

4.12.1.3 The Department ofHealth, for biosafetydecisions concerningpharmaceuticals forhumans that are notexplicity excluded underArticle 5 of the Protocol,i.e. pharmaceuticalswhich are not addressedby other relevant interna­tional agreement ororganizations; and,

4.12.1.4 The Department of Envi­ronment and NaturalResources, for biosafetydecisions covered by theProtocol that concernregulated organismsintended or bioremedia­tion, the improvementof forest geneticresources, and wildlifegenetic resources, andapplications of modembiotechnology withpotential impact on theconservation and sustain­able use of biodiversity.

4.12.2 The national focal point and the• competent authorities listed above

shall, as appropriate, coordinatewith the NCBP in accordance withthe mandate under Section 4.1.For genetically modifiedorganisms not falling under thejurisdiction of the competentauthorities enumerated above, theNCBP shall designate theappropriate agency that shall actas such authority.

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4.13 Biosafety Clearing House.-Concernedgovernment departments and agencies shallutilize the Biosafety Clearing House(BCH) of the Cartagena Protocol onBiosafety in developing and adoptingbiosafety policies, guidelines, andmeasures and in making biosafetydecisions. The NCBP Secretariat shallserve as die focal point for the BCH incoordination with the DENR-PAWBserving as the focal point for the ClearingHouse Mechanism (CHM) of theConvention of Biological Diversity.

4.14 Role of Stakeholders and the Public.­The role of relevant stakeholders and thepublic in biosafety decisions is providedfor in Sections 6 and 7 of this Framework.

SEC. 5. DECISION-MAKING PROCESSES

Biosafety decisions shall be made in accordancewith existing laws and the following guidelines:

5.1 Standard of Precaution.-In accordancewith Article 10 (par. 6) and Article 11 (par.8) of the Cartagena Protocol on Biosafety,lack of scientific certainty or consensusdue to insufficient relevant scientificinformation and knowledge regarding theextent of the potential adverse effects of agenetically modified organism on theenvironment, particularly on theconservation and sustainable use ofbiological diversity, and on human health,shall not prevent concerned governmentdepartments and agencies from taking theappropriate decision to avoid or minimizesuch potential adverse effects. In suchcases, concerned government departmentand agencies shall take the necessaryaction to protect public interest andwelfare.

5.2 Risk Assessment.-Risk assessment (RA)shall be mandatory and central in makingbiosafety decisions. It shall identify andevaluate the risks to human health and theenvironment, and if applicable, to animalhealth.

5.2.1 Principles of Risk Assessment.­The following principles shall befollowed when performing a RA todetermine whether a regulatedarticle poses significant risks tohuman health and the environment:

5.2.1.1 The RA shall be carried outin a scientifically sound and

. transparent manner basedon available scientific andtechnical information. Theexpert advice of andguidelines developed by,relevant internationalorganizations, includingintergovernmental bodies,and regulatory authoritiesof countries withsignificant experience inthe regulatory supervisionof the regulated article shallbe taken into account in theconduct of risk assessment.

5.2.1.2 Lack of scientific knowl­edge or scientific consen­sus shall not be interpretedas indicating a particularlevel of risk, an absence ofrisk, or an acceptable risk;

5.2.1.3 The identified characteris­tics of a regulated articleand its use which have thepotential to ,Pose significantrisks to human health andthe environment shall becompared to thosepresented by the non­modified organism fromwhich it is derived and itsuse under the sameconditions;

5.2.1.4 The RA shall be carriedout case-by-case and on

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5.3 Role of Environmental ImpactAssessment.-The application of the EIASystem to biosafety decisions shall bedetermined by concerned departments andagencies subject to the requirements of lawand the standards set by the NCBP. Whereapplicable and under the coordination of

5.2.2 Risk AssessmentGuidelines.-Theconduct of RA by concerneddepartments and agencies shall bein accordance with the policies andstandards on RA issued by theNCBP. Annex III of the CartagenaProtocol shall also guide RA. Asappropriate, such department andagencies may issue their ownrespective administrative issuancesestablishing the appropriate RAunder their particular jurisdictions.

5.2.1.5

the basis of transforma­tion event. The requiredinformation may vary innature and level of detailfrom case to case de­pending on the regulatedarticle concerned, itsintended use and thereceiving environment;and

If new information on theregulated article and itseffects on human healthand the environmentbecomes available, andsuch information isrelevant and significant,the RA shall be re­addressed to determinewhether the risk haschanged . or whetherthere is a need to amendthe risk managementstrategies accordingly.

the NCBP, concerned departments andagencies shall issue joint guidelines on thematter.

5.4 Socio-economic, Ethical, Cultural andOther Considerations.-Consistent withArticle 26 of the Cartagena. Protocol,concerned government departments andagencies may take into account socio­economic considerations arising from, theimpact of regulated articles on theconservation and sustainable use ofbiological diversity, especially with regardto the value of biological diversity toindigenous and local communities.

The NCBP shall issue guidelines consistent withinternationally accepted standards relating to theconduct of social, economic, ethical, culturaland other assessments, as appropriate; prior todecisions to commercialize products of modembiotechnology.

These assessments shall be conducted separatelyfrom risk assessment and in a transparent,participatory and rigorous manner.

5.5 Decisions under the CartagenaProtocol.-For decisions required underthe Cartagena Protocol on Biosafety, thecompetent national authorities identifiedmay choose to adopt the procedures of theAdvance informed Agreement as providedin Articles 7, 8, 9, 10, 11, 12 and 13 ofthe Protocol or issue their own respectiverules and regulations provided that suchrules and regulations are consistent withthe Protocol. In all cases, decisions underthis Framework shall fall within thosetimeframes required under the CartagenaProtocol. As provided however in theProtocol, failure to comply with suchtimeframes shall not imply consent to anintentional trans boundary movement ofgenetically modified organisms coveredunder the Protocol.

MAY 22, 2006 OFFICIAL GAZETTE 3309

5.6 Monitoring and Enforcement.-Allconcerned departments and agencies shallmonitor compliance to the conditionsattached to approvals and authorizations,especially on risk management, in amanner that is transparent, and incoordination with other agencies, includingLGUs, and other stakeholders.

It shall also include monitoring for impacts,whether anticipated or not, of the introducedproduct on environment and health.

SEC. 6. ACCESS TO INFORMATION

The right of the public and the relevantstakeholders to information related to biosafetydecisions is recognized and shall always berespected in accordance with guidelines to beissued by the NCBP, which shall include, amongothers, the following:

6.1 Information on Applications.-Concerneddepartments and agencies shall, subject toreasonable limitations to protectconfidential information as providedbelow, disclose all information on suchapplications in a prompt and timelymanner. Such departments and agenciesmay require applicants to provide theinformation directly to concernedstakeholders.

6.2 Confidential Information.-In allapplications for approvals, whetherdomestic or foreign, concerneddepartments and agencies shall ensure thatit has procedures and regulations todetermine and protect confidentialinformation; Provided, however, that theconcerned agencies may refuse declaringthe confidentiality of such information ifit is necessary to enable the concernedstakeholders to effectively conduct ascientific risk assessment.

6.3 Information on BiosafetyDecisions>-Thepublic and stakeholders shall have access

to all biosafety decisions and theinformation on which they are based,subject to limitations set in Section 6.2 ofthis Framework. Such decisions shallsummarize the application, the results ofthe risk assessment, and other relevantassessments done, the public participationprocess followed, and the basis forapproval or denial of the application.

6.4 Information on Risk Management,Product Monitoring, and Productidentification.-All relevant stakeholdersshall have access to information related torisk management and product monitoring.Information on product identification shallbe provided to the general public.

SEC. 7. PUBLIC PARTICIPATION

The concerned government departments andagencies, in developing and adopting biosafetypolicies, guidelines and measures and in makingbiosafety decisions, shall promote, facilitate, andconduct public awareness, education,meaningful, responsible and accountableparticipation. They shall incorporate into theirrespective administrative issuances andprocesses best practices and mechanisms onpublic participation in accordance with thefollowing guidelines:

7.1 Scope of Public Participation.-Publicparticipation shall apply to all stages ofthe biosafety decision-making processfrom the time the application is received.For applications on biotechnologyactivities related to research anddevelopment, limited primarily forcontained use, notice of the filing of suchapplication with the NCBP shall besufficient, unless the NCPB deems thatpublic interest and welfare requiresotherwise.

7.2 Minimum Requirements of PublicParticipation.-In conducting public

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participation processes, the followingminimum requirements shall be followed:

7.2.1 Notice to all concernedstakeholders, in a languageunderstood by them and throughmedia to which they have access.Such notice must be adequate,timely, and effective and postedprominently in public places in theareas affected, and in the case ofcommercial releases, in the nationalprint media; in all cases, suchnotices must be postedelectronically in the internet;

7.2.2 Adequate and reasonable timeframes for public participationprocedures. Such proceduresshould allow relevant stakeholdersto understand and analyze' thebenefits and risks, consult withindependent experts, and maketimely interventions. Concerneddepartments and agencies shallinclude in their appropriate rulesand regulations specific time framesfor their respective publicparticipation processes, includingsetting a minimum time frame asmay be appropriate;

7.2.3 Public consultations, as a way tosecure wide input into the decisionsthat are to be made. These couldinclude formal hearings in certaincases, or solicitation of publiccomments, particularly where thereis public controversy about theproposed activities. Publicconsultations shall encourageexchanges of information betweenapplicants and the public before theapplication is acted upon. Dialogueand consensus-building among allstakeholders shall be encouraged.Concerned departments and

agencies shall specify in theirappropriate rules and regulations thestages when public consultations areappropriate, the specific time framesfor such consultations, and thecircumstances when formal hearingswill be required, includingguidelines to ensure orderlyproceedings. The networks ofagricultural and fisheries councils,indigenous peoples and community­based organizations in affected areasshall be utilized;

7.2.4 Written submissions. Procedures forpublic participation shall includemechanisms that allow publicparticipation in writing or throughpublic hearings, as appropriate, andwhich allow the submission of anypositions, comments, information,analyses or opinions. Concerneddepartments and agencies shallinclude in their appropriate rulesand regulations the stages when andthe process to be followed forsubmitting written comments; and,

7.2.5 Consideration ofpublic concerns inthe decision-making phase followingconsultation and submission ofwritten comments. Public concernsas reflected through the proceduresfor public participation shall beconsidered in making the decision.The public shall be informed of thefinal decision promptly, have accessto the decision, and shall beprovided with the reasons andconsiderations resulting in thedecisions, upon request.

SEC. 8. CAPACITY BUILDING ANDFINANCIAL RESOURCES

Implementing the NBF requires the design,adoption and implementation of a capacity-

MAY 22,2006 OFFICIAL GAZETTE 3311

building program supported by adequatefinancial resources. The followingconsiderations shall be taken into account indeveloping such a program:

8.1 Need for Capacity Building.-To ensurethe proper implementation of the NBF, thecapacities of various sectors: policy­makers, regulatory agencies, localgovernment units, research community andthe general public involved in performingvarious tasks shall be strengthened;

(a) Policy makers shall be made awareof issues and provided with sufficientand most current information onbiosafety for the enactment ofappropriate policies, regulations andprograms;

(b) Expertise and appropriate facilities inregulatory agencies shall bedeveloped for the safety assessmentof regulated articles, harmonizationof regulatory policies and proceduresand monitoring compliance andoutcomes to biosafety regulations;

(c) The research community shall besupported to enable them to addressthe safety issues of regulated articles;and,

(d) The general public shall be madeaware of issues, provided with thecorrect information and enabled toparticipate in the biosafety decision­making process. The capacity ofenvironmental and developmentalnon-government organizations,people's organizations, professionalorganizations, including industry andother concerned entities to assist inthis capacity-building program shallbe enhanced. Agencies involved inimplementing the NBF shouldundertake programs to achieve theabove objectives.

8.2 Areas for Capacity Building.-Capacitybuilding in all areas relevant to biosafety.and biosafety-decision making isnecessary, and· particularly in thefollowing: in conducting risk assessment,in undertaking social, economic, cultural,ethical and other assessments; and, inimplementing transparent and effectivepublic participation procedures.

8.3 Designing and Implementing a Capacity­Building Program.-In coordination withother concerned government departmentand agencies, and with the participationof all relevant stakeholders, the NCBPshall take the lead in developing andimplementing multi-agency and multi­sector capacity-building programs that areneeded for the effective implementationof the NBF. The basis of such programsshall be a capability needs assessmentundertaken by each concerned departmentand agency and by the relevantstakeholders.

8.4 Financial Resources.-The DOST,DENR, DA and DOH shall allocate fromtheir present budgets such amount as maybe necessary to implement the NBF,including to support the operations of theNCBP and its Secretariat. Thereafter, thefunding requirements shall be included inthe General Appropriations Bill submittedto Congress.

These concerned departments, on an annual orother periodic basis, shall enter into agreementon the sharing of financial and technicalresource to support the NCBP and itsSecretariat.

SEC. 9. REMEDIES

In cases of violations of laws, rules andregulations related to biosafety, the followingremedies shall apply:

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9.1 Administrative Remedies.-The concerneddepartments and agencies shall ensure, inaccordance with law, that the right ofappeal and other administrative remediesare available to applicants and relevantstakeholders in biosafety decisions.

9.2 Criminal Liability.-Natural or juridicalpersons committing offenses in violationof existing laws shall be prosecuted andpenalized in accordance with such laws.

9.3 Civil Liability.-Philippine laws onliability and compensation for damagesresulting injuries committed on personsshall apply in accordance with such laws.

9.4 International Law.-International legalnorms on liability and compensation,including those developed and adoptedunder the Cartagena Protocol on Biosafety,shall likewise apply.

SEC. 10. REYIEW

The NBF shall be reviewed periodically toidentify gaps and lessons learned from itsimplementation and to incorporate new

information that may lead to its improvement.The NCBP shall initiate and lead such reviewevery five years from effectivity date of thisOrder, unless in its determination circumstances,such as emergencies or new developments inscience and technology, require an earlierreview.

10.1 Review Process.-The review shall beinitiated by the NCBP and shall involveconcerned departments and agencies.Public consultations, in accordance withSection 6, shall be undertaken wheneversubstantive changes are proposed to theFramework.

10.2 Process of Delisting.-Delisting ofregulated articles shall rest on theregulatory agencies, subject to guidelinesset under the NCBP process. The NCBPshall initiate a study on the feasibility ofa delisting procedure for regulated articles.

10.3 Legislation.-Lessons learned fromimplementing the Framework shall bedocumented and, at an appropriate time,conveyed to Congress for purposes ofdeveloping, drafting and adoptinglegislation on biosafety.