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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
Consistent Philippine Government Consistent Philippine Government Policy on Biotechnology (1979Policy on Biotechnology (1979--date)date)
“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
Consistent Philippine Government Consistent Philippine Government Policy on Biotechnology (1979Policy on Biotechnology (1979--date)date)
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?
STRPFor evaluation on risk assessment
Process & evaluate within 5 days of receipt
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
Within 90 days from acceptance
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
Shall submit report w/n 30 days
BAFPS
FPA
BAI
In all instances
If pest-protected plant
If intended as feed
Shall submit report w/n 30 days
Shall submit report w/n 30 days
Shall submit report w/n 30 days
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?
Process & evaluate within 5 days of receipt
YESNO
Submit:• 2 copies of Petition• published scientific literature relied upon
Within 120 days from acceptance
STRPFor evaluation on risk assessment
For publication of petition
PetitionerShall publish petition in 2 papers, & invite comments w/in 60-day pd.
Shall submit report w/n 30 days
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