Philippine Biotechnology Policy - RISris.org.in/images/RIS_images/pdf/asianbio2006_Segfredo_Serrano.pdf · Agriculture and Fisheries Modernization Act (AFMA) of 1997 Transform the

Philippine Biotechnology PolicyPhilippine Philippine Biotechnology PolicyBiotechnology Policy

Dr. Segfredo R. SerranoUndersecretary

Philippines Department of Agriculture

Philippine Biotechnology PolicyPhilippine situation

Rapidly increasing populationAnnual growth rate of >2%Significant number – poor

Diminishing land area due to agricultural land conversion

Increased demand for industrial and residential areasLand reform

Increasing energy costRising cost of agri inputs

Diminishing fresh water supply

Philippine Situation

Net importer of foodImporter of GM commodities

- 99% soybean needs imported- corn- rice

Agricultural Imperative

Produce more food per unit land, per unit input amid concerns forSustainability of productionEnvironmental integrityFood safety & human healthRural povertyFood security

Consistent Philippine Government Consistent Philippine Government Policy on Biotechnology (1979Policy on Biotechnology (1979--date)date)

Ferdinand E. Marcos (1979)– established BIOTECH, UPLB– first Philippine biotechnology R & D institution

Corazon C. Aquino (1990)– EO430-modern biotechnology regulation

R & D - NCBP, – biotechnology high priority in S & T

Fidel V. Ramos (1997)– first National Modern Biotechnology R & D Program

in Agriculture– signed AFMA into law (support for agricultural biotech)

Joseph Ejercito Estrada– signed statement in support of agricultural biotechnology


“We shall promote the safe and responsible use of modernbiotechnology and its products as one ofthe means to achieve food security, equal access to health services, a sustainable and safe environment, andindustry development.”

President Gloria Macapagal Arroyo 16 July 2001


Agriculture and Fisheries Modernization Act (AFMA) of 1997

Transform the Philippine agriculture and fisheries sectors from a resource-based to a technology-based industryProvides budget for biotechnology

Philippine Biosafety Measures1. Executive Order 430 of 19902. NCBP Guidelines on Planned Release3. DA Administrative Order 8 and attendant

Memorandum Circulars4. Executive Order 514 of 20065. Cartagena Protocol on Biosafety

DA Administrative Order No. 8 (s. 2002)

“Rules and regulations on the importation and release into the environment of plants and plant materials derived from the use of modern biotechnology” by Secretary Leonardo Q. Montemayor on April 3, 2002

- addresses risks of GM plant and plant products to human and animal health, and the environment

DA Administrative Order No. 8 (s. 2002)

Risk assessment policy

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

Legal Basis for AO 8 Legal Basis for AO 8 Plant Quarantine Act (BPI) Plant Quarantine Act (BPI) Agriculture and Fisheries Modernization Act (AFMA)Agriculture and Fisheries Modernization Act (AFMA)Existing mandates of BAI and FPAExisting mandates of BAI and FPAExecutive Order 430 of 1990Executive Order 430 of 1990

Features Simplified Approval ProcessSimplified Approval Process–– An Issuing Authority (BPI)An Issuing Authority (BPI)–– Regulatory agencies (BAI, BAFPS, FPA) Regulatory agencies (BAI, BAFPS, FPA)

perform risk assessmentperform risk assessment–– Single Entry Point for ApplicationSingle Entry Point for Application–– An independent nonAn independent non--DA risk assessment DA risk assessment

through the Scientific and Technical Review through the Scientific and Technical Review Panel (STRP)Panel (STRP)

Public Input Into The ProcessPublic Input Into The Process

CoverageCoverage11 Any plant which has been altered or produced Any plant which has been altered or produced

through the use of modern biotechnology if through the use of modern biotechnology if donor organism, host organism, or vector or donor organism, host organism, or vector or vector agent belongs to any of the genera or taxa vector agent belongs to any of the genera or taxa classified by BPI as meeting the definition of classified by BPI as meeting the definition of plant pest or is a medium for the introduction of plant pest or is a medium for the introduction of noxious weedsnoxious weeds

CoverageCoverage22 Any plant or plant product altered or produced Any plant or plant product altered or produced

through the use of modern biotechnology through the use of modern biotechnology which may pose significant risks to human which may pose significant risks to human health and the environment based on available health and the environment based on available scientific and technical informationscientific and technical information

PrinciplesPrinciples11 Carried out in scientific & transparent manner; Carried out in scientific & transparent manner;

based on available scientific & technical based on available scientific & technical informationinformation

22 Lack of scientific knowledge or consensus not to Lack of scientific knowledge or consensus not to be interpreted as indicating a particular level of be interpreted as indicating a particular level of risk, absence of risk, or acceptable riskrisk, absence of risk, or acceptable risk

PrinciplesPrinciples3.3. Identified characteristics of GMO and its use shall be Identified characteristics of GMO and its use shall be

compared to those of noncompared to those of non--GMO from which it is GMO from which it is derived and its use under the same conditionsderived and its use under the same conditions

4.4. To be carried out caseTo be carried out case--byby--case and on the basis of case and on the basis of transformation eventtransformation event

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

Responsible OfficerResponsible OfficerThe applicant for the import or release into the The applicant for the import or release into the environment of GMO shall appoint a Responsible Officer environment of GMO shall appoint a 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 measures are taken who shall ensure that all appropriate measures are taken to prevent adverse effects on human health and the to prevent adverse effects on human health and the environment.environment.

For communication purposes, RO may designate a duly For communication purposes, RO may designate a duly authorized representativeauthorized representative

TYPES OF PERMITTYPES OF PERMIT1.1. To Import for Contained Use To Import for Contained Use 2.2. To Field TestTo Field Test3.3. To PropagateTo Propagate4.4. To Import for Direct Use as Food or To Import for Direct Use as Food or

Feed, or for ProcessingFeed, or for Processing

WHO CAN APPLYWHO CAN APPLYAny JuridicalAny Juridical person who has and will maintain person who has and will maintain control over the importation or release of the GMO. It control over the importation or release of the GMO. It may be:may be:

departments or agencies of the Government of the departments or agencies of the Government of the PhilippinesPhilippinesuniversityuniversity--based research institutions in the Philippinesbased research institutions in the Philippinesduly recognized international research organization based duly recognized international research organization based in the Philippinesin the Philippinescorporations registered with the SECcorporations registered with the SECcooperatives registered with the CDAcooperatives registered with the CDA

POLICY ON FIELD TESTINGPOLICY ON FIELD TESTING““No regulated article shall be released into the

environment for field testing unless: (i) a Permit to Field Test has been secured from the

BPI; and,(ii) the regulated article has been tested under

contained conditions in the Philippines.

APPLICATION TO FIELD TEST

Applicant

BPI

Sufficient in Form &

Substance?

Public Hearing by IBC (if STRP reports that release may pose significant risks

Process & evaluate within 5 days of receipt

YESNO

Submit:• 3 copies of Application Form• support documents (technical dossier; copy of PIS; & NCBP certification that reg.art. has undergone satisfactory testing for contained use in the Phils.

APPROVED

DENIED

Within 120 days from acceptance

If reg. art. is to be imported:• certification fr. country of import that reg.art. is of similar transformation event approved locally; • notification fr. country of import in accordance w/ existing international agreements on GMOs

Grace period of 60 days to correct defects

For conduct of public consultation

Applicant thru IBC

Shall post PIS for 3 consecutive wks, & invite comments w/in 30-day pd.

STRPFor evaluation on risk assessment

Shall submit report w/n 30 days

For consultation NCBP

POLICY ON RELEASE FOR POLICY ON RELEASE FOR PROPAGATIONPROPAGATION

““No regulated article shall be released for propagation No regulated article shall be released for propagation unless: unless:

(i)(i) a a Permit for PropagationPermit for Propagation has been secured from BPI; has been secured from BPI; (ii)(ii) it can be shown that based on field testing conducted it can be shown that based on field testing conducted

in the Philippines, the regulated article will not pose in the Philippines, the regulated article will not pose any significant risks to the environment; any significant risks to the environment;

(iii)(iii) food and/or feed safety studies show that the regulated food and/or feed safety studies show that the regulated article will not pose any significant risks to human and article will not pose any significant risks to human and animal health; and,animal health; and,

(iv)(iv) If the regulated article is a pestIf the regulated article is a pest--protected plant, it has protected plant, it has been duly registered with the FPA.been duly registered with the FPA.””

Applicant

BPI

Sufficient in Form &

Substance?



YES

APPLICATION TO RELEASE FOR PROPAGATION For conduct of

public consultation

NO

Submit:• 5 copies of Application Form• support documents (technical dossier; copy of PIS; & BPI certification that reg.art. has undergone satisfactory field testing in the Phils.

APPROVED

DENIED


Applicant

If reg. art. is to be imported:• certification fr. country of import that reg.art. is of similar transformation event approved locally; • notification fr. country of import in accordance w/ existing international agreements on GMOs

Grace period of 60 days to correct defects


BAFPS

FPA

BAI

In all instances

If pest-protected plant

If intended as feed




Shall publish PIS in 2 papers, & invite comments w/in 30-day pd.

DELISTING OF REGULATED ARTICLEDELISTING OF REGULATED ARTICLE

If based on the nature of a regulated article and its use, the regulated article will not pose any significant risks to human health and the environment, BPI may remove it from the coverage of this Order.

Petitioner

BPI

Satisfactory Requirements?


YESNO

Submit:• 2 copies of Petition• published scientific literature relied upon



For publication of petition

PetitionerShall publish petition in 2 papers, & invite comments w/in 60-day pd.


APPROVED

ADD’L DATA REQUIRED

DENIED

PETITION FOR DELISTING

CONFIDENTIAL BUSINESS CONFIDENTIAL BUSINESS INFORMATIONINFORMATION

Upon prior consultation with the applicant, the BPI Upon prior consultation with the applicant, the BPI can declare and designate certain portions of the can declare and designate certain portions of the application, which contain trade secrets or application, which contain trade secrets or confidential business information, as such. confidential business information, as such.

Memorandum Circular 8 (May 15, 2003)

“Guidelines for the Phytosanitary Inspection of Regulated Articles for Food, Feed and for Processing Pursuant to AO 8”

Requires Declaration of GMO Content for Each ShipmentApproval Registry for GM Crops for food, feed or for processing

Memo Circular 8 (May 15, 2003)

Declaration of GMO ContentThe shipment may contain a GM ingredient:

Yes _____ No _____If yes, list the probable transformation events.

To be filled up by the PQS OfficerTo be filled up by the PQS Officer

In the Approval RegistryIn the Approval Registry Not in the Approval RegistryNot in the Approval Registry

______________________________________ ____________________________________________

______________________________________ ____________________________________________

______________________________________ ____________________________________________

[Signature][Signature]

Plant Quarantine Officer

PresentPresent

____________

____________

____________

Plant Quarantine Officer[Signature][Signature]

Responsible Officer from the Country of Origin/Accredited Responsible Officer from the Country of Origin/Accredited Laboratory/Importer/ShipperLaboratory/Importer/Shipper

Memo Circular No. 17 ( Dec 23, 2003) Additional Requirements for the Insect Resistance Management (IRM) Strategy in Bt Corn

Memo Circular No. 6 ( Sept 16, 2004) Risk assessment of plants carrying stacked genes for release into the environment

Memo Circular No. 8 (Oct 11, 2004) Risk assessment for stacked gene products imported for direct use as food, feed or for processing

Implementation of AO 8 Per BPI Approval registry:1. Approved for field trials- 1 corn event (NK603) – 2 projects- 1 stacked corn NK603x MON810- 1 corn event TC 1507

2. Approved for import for direct use as food, feedand for processing

- 25 events: 7 crops ( corn, potato, canola, cotton, sugarbeet, soybean, and alfalfa)

- 11 stacked trait products (corn, cotton)

3. Approved for propagation (3 events & 1 combined trait)- Corn MON810- Corn Bt11- Corn NK603- Corn NK603 x Corn MON810

Capability Training

1.Training program for assessors (Biotech Core Teams, STRP)- Lectures – Introduction to modern biotech principles, concepts & practice of risk assessment of GM crops

- Visits to biotech labs, field trials, commercial farms- Attendance to training courses abroad – USDA, ASEAN,ILSI, ISAAA, SEAMIC/IMFJ

2. Lab personnel – introduction to modern biotech, lab techniquesin molecular biology & GMO detection

3. Public information campaign

4. Establishing GMO detection labs – BPI

DA Biotechnology Program

Research for technology development- 3-in-1 Rice (virus & bacterial blight resistant, high pro-vitamin A rice)

- virus-resistant abacaRDE for industrial development

- natural ingredients industryPromotion of investments in exports

- natural ingredients- PMPs

Biotechnology

… Changing the face of Philippine agriculture

… Improving farmers lives

… Achieving food security in a sustainable manner

Thank you Thank you

Documents

Philippine Biotechnology Policy - RISris.org.in/images/RIS_images/pdf/asianbio2006_Segfredo_Serrano.pdf · Agriculture and Fisheries Modernization Act (AFMA) of 1997 Transform the