Biosafety Regulations in the Biosafety Regulations in the Philippines: Past, Present & Philippines: Past, Present & FutureFuture

Jose Maria A. OchaveJose Maria A. OchaveFormer Member and Legal Adviser, NCBP Former Member and Legal Adviser, NCBP Current Member and Legal Adviser, DOST Biosafety CommitteeCurrent Member and Legal Adviser, DOST Biosafety Committee

Biosafety Regulations: Opening Up the DebateLessons from Kenya and the PhilippinesNairobi, KenyaNovember 15-16, 2010

Outline of Presentation

• Introduction– State Policy on Modern Biotechnology– Regulatory Architecture

• Primary Regulatory Instruments and Approvals

• Defining Moment - The Bt Corn Experience• Concluding Remarks: After Twenty Years

State Policy on Modern BiotechnologyIssued on 16 July 2001by the President of the Philippines

“We shall promote the safe and responsible use of modern biotechnology and its products as one of several means to achieve and sustain food security, equitable access to health services, sustainable and safe environment, and industry development”

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Stages in the development of GMOs requiring regulatory approvals

• Contained use (laboratory, greenhouse, screenhouse)

• Confined environmental release

• Large Scale release• Unconfined environmental

release (commercialization)• Use for Food, Feed and For

Processing

Twenty Years of Biosafety Regulation • Originally, regulation was through a multi-sectoral, inter-agency National Committee on Biosafety of the Philippines (NCBP) established on October 15, 1990 under E.O. No 430 and working through the line agencies. NCBP was composed of 10 members: 4 scientists, 2 community representatives, and representatives of 4 line agencies (DENR, DA, DOST and DOH).

• In 2006, E.O. 514 created a new NCBP composed 15 members: 5 scientists, 1 representative each of consumers, industry and community, and representatives 7 line agencies (DENR, DA, DOST, DOH, DFA, DILG, DTI). Risk assessment and approvals are by line agencies.

E.O. 430, s. 1990 (NCBP)Contained use

Department of Agriculture Administrative Order No. 8, s. 2002

Field testing and commercialization, Direct Use for food, feed & processing

E.O. 514, s. 2006

National Biosafety Framework (NBF)

PRSV-resistant Papaya

PCR

Harvest of Xa-21 riceIRRI

Primary Regulatory Instruments

Executive Order No. 430, Series of 1990

Scope: Contained Use Confined Use Originally, limited field testing Potentially harmful exotic species

E.O. 430, s. 1990• Established the NCBP due to advocacy efforts of

scientists • Mandate of NCBP:

1. Identify and evaluate potential hazards in GE experiments

2. Formulate and review national policies on biosafety and guidelines in risk assessment

3. Develop working arrangements with quarantine services in evaluation, monitoring & review of projects

4. Assist in development of technical expertise for quarantine services & risk assessment

5. Recommend development and promotion of research programs to establish risk assessment protocols and assessment of long-term effects of bio research

6. Publish results of internal deliberation and agency reviews

7. Provide assistance in formulation, amendment or pertinent laws, rules and regulations

8. Call upon the assistance of any government agency or GOCC.

Contained use• Work is done under containment, i.e.

laboratory, greenhouses or screenhouses, confined field

• Physical, spatial, biological isolation is imposed to ensure that no viable GMOs or microorganisms are introduced into the environment

• Activities are generally performed subject to specific biosafety guidelines and under specific levels of containment

• Biosafety guidelines series 1 and Planned Release of GMOs and PHES, series of 1998 are used

Information requirements for EVALUATING WORK UNDER CONTAINMENT

Transformation protocol (biolistic, Agrobacterium-mediated

Genetic & physiological analyses of donor and recipient organisms Adequacy of the facility, (level of containment will depend on the type of

work to be conducted) Biosafety measures, i.e. disposal procedures

Greenhouse/Screenhouse :

Potential ecological impacts Genetic stability of GMOs Reaction/interaction with organisms found in actual ecosystems

Applications received: 248Applications approved: 204 Lab and screenhouse; 9 Confined field tests

Golden riceIBS lab inspection

IRRI CL4 facility

TransformationIRRI biological cabinet

Golden rice exptIRRI screenhouse

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Confined field releases: Crops and events eligible for confined tests:

• GM crops whose size & growth habits require areas not afforded by standard screenhouse, i.e. papaya

• GM crops already commercially available in the country where they were developed, if sufficient info relevant to RP are available

• Locally developed GM crops with sufficient information generated in the lab/screenhouse – sufficient for RA

• Other crops and events that warrant limited release under contained confined conditions

Confined Field tests• Confined Field Test of Pro-Vitamin A enriched

‘golden rice’ introgressed lines of IR64, IRRI, Approved: Dec. 2007

• Development and Commercialization of PRSV Resistant GM Papaya for Fresh Fruit and Papain Production: Confined Trial for Generation Advance and Line Selection in Candidate PRSV-CP Transformation Events (E-124, E-132 and E-142) and Other Biosafety-Related Studies

Confined field test: 2 sites (2007-2009)

Researches by Public Research Institutions

• Papaya ringspot virus (PRSV) resistant and delayed ripening transgenic papaya

• Banana bunchy top virus (BBTV) resistant transgenic banana

• Regeneration and transformation of mango & coconut

• Bt eggplant• Virus resistant tomato• Beta carotene rice

1998: Planned Release guidelines on GMOs and PHES

10 applications for field testing of insect resistant and herbicide tolerant corn, and combination of two traits

Carried out in Isabela, Pangasinan, Bicol, Bukidnon, North and South Cotabato and Lanao del Sur.

Xa-21 (blight resistance) PhilRice and IRRI: 2 seasons 2001-2003

Heat treatment

Plowing underData gathering Post harvest monitoring

Department of AgricultureAdministrative Order No. 8,

Series of 2002

Scope: Field testing Commercialization/Propagation Use of GMOs for Food, Feed and For Processing Delisting

D.A.-A.O. No. 8, Series of 2002

• Served to formalize existing arrangements between NCBP and Department of Agriculture

• Transferred field testing decision-making to the agency most equipped to handle it.

• Ensures that socio-economic considerations are included in decision-making process.

No person shall be allowed to No person shall be allowed to import or release into the import or release into the environment any regulated article environment any regulated article without a satisfactory risk without a satisfactory risk assessment conducted in accordance assessment conducted in accordance with the Rules.with the Rules.

Risk Assessment Risk Assessment PolicyPolicy

1.1. Carried out in scientific & transparent Carried out in scientific & transparent manner; based on available scientific manner; based on available scientific & technical information& technical information

2.2. Lack of scientific knowledge or Lack of scientific knowledge or consensus not to be interpreted as consensus not to be interpreted as indicating a particular level of risk, indicating a particular level of risk, absence of risk, or acceptable riskabsence of risk, or acceptable risk

Risk Assessment Risk Assessment PrinciplesPrinciples

3.3. To be carried out on a case-by-case To be carried out on a case-by-case basisbasis

4.4. Identified characteristics of GMO and Identified characteristics of GMO and its use shall be compared to those of its use shall be compared to those of non-GMO from which it is derived and non-GMO from which it is derived and its use under the same conditionsits use under the same conditions

5.5. If new information becomes available, If new information becomes available, risk assessment shall be readdressedrisk assessment shall be readdressed

Applicant for the import or release into the Applicant for the import or release into the environment of GMO shall appoint a environment of GMO shall appoint a Responsible Officer –Responsible Officer –

its highest ranking officer its highest ranking officer andand resident of the Philippines –resident of the Philippines –

who shall ensure that all appropriate who shall ensure that all appropriate measures are taken to prevent adverse measures are taken to prevent adverse effects on human health and the effects on human health and the environment.environment.

Responsible OfficerResponsible Officer

TYPES OF PERMITTYPES OF PERMIT

Permit to Import GMOs Permit to Import GMOs Permit for Limited Release into the Permit for Limited Release into the

EnvironmentEnvironment Permit for General Release into the Permit for General Release into the

EnvironmentEnvironment

Completed Field tests under A.O.#8 (10)

Round-up ready (DK818/NK603)Round-up herbicide (360 g ge/L IPA salt)MON 810/NK603Herculex IHerbicide tolerant Maize (GA21)Papaya with delayed ripening traitAgronomic equivalency MON89034, Agronomic performance of MON89034; MON89034/NK603 Multilocation trials of Stacked trait Bt11xGA21

D

Approved Transformation Events for Propagation

Corn (5): MON 810, Bt 11, NK603 GA21, MON810/NK603 (stacked)

Approved for Direct Use as Food, Feed or Processing 49 Articles, 19 Events, 19 stacks

(Corn, soybean, potato, sugarbeet, canola and cotton; 2 traits – Insect resistance & Herbicide tolerance)

D

Executive Order No. 514, Series of 2006

- The result of a UNEP-funded project.- Established the so-called National - Established the so-called National Biosafety Framework, which was essentially Biosafety Framework, which was essentially a description of a regulatory framework that a description of a regulatory framework that was already in existence.was already in existence.- Created a New NCBP, a super-bodyCreated a New NCBP, a super-body- Identified the national competent Identified the national competent authorities for purposes of the Cartagena authorities for purposes of the Cartagena ProtocolProtocol

E.O. No. 514, series of 2006

• New NCBP to: – coordinate and harmonize inter-agency and

multi-sector efforts in developing biosafety policies, setting scientific, technical & procedural standards on biosafety

– oversee the implementation of the National Biosafety Framework

– act as clearing house for biosafety matters

Defining Moment

The Bt Corn Experience• August-December 1996: First greenhouse evaluation of Bt

corn expressing Bt CryllA(b) gene under CL4 confinement facility at IRRI using transgenic hybrid materials from Pioneer Hi-Bred

• 1997-1998: Second greenhouse evaluation with Event 176 with materials from CIMMYT under CL4 confinement facility

• December 1999-March 2000: Limited field trial evaluation in General Santos City by IPB-UPLB and Agroseed Corporation

• 2001-2002: Multi-location field trials by Monsanto and Pioneer Hi-Bred

• [2003: Bt corn approved for commercialization]*

* By the Department of Agriculture

The Bt Corn Approval

• The Bt Corn episode:– Was NCBP’s first encounter with those opposed to modern

biotechnology– Forced NCBP and scientists to explain biotechnology to laymen – Highlighted the fact that biosafety is not only science-based risk

assessment, but involves other issues which NCBP is ill-equipped to handle

• NCBP was later criticized because:– Risk management measures required of the applicant were too

strict – It took a long time to approve the application – It was very expensive for the applicant

1st Limited Field trial: MON810 Agroseed Corporation , 25 August 1999 to 18 March

2000 Risk mitigation measures: Reproductive and Spatial isolation: Detasseling ; 500 meters isolation distance; Enclosure of the experimental area with 10 feet synthetic

cloth

After Twenty Years . . . After Twenty Years . . .

Functional biosafety regulatory system Rigorous/Robust Risk assessment First country in Asia to commercialize GMOs 49 Approvals for food, feed and processing Guidelines for agricultural crops in place; Harmonization between and among regulatory agencies continues Compliant with international obligations as per Cartagena Protocol on Biosafety Established the BCH Pilipinas: Biosafety Clearing House

Thank you

Please feel free to access our websites:

NCBP: http://www.ncbp.dost.gov.phApprovals on contained use and field testings till 2002Department of Agriculturehttp://www.da.gov.phApproved Field tests, Commercial release, Direct Use

BCH Pilipinas: http://bch.dost.gov.phApprovals for direct useLink to the BCH Central Portal

* Some slides supplied by Ms. Julieta Fe Estacio, Head of NCBP Secretariat.