Hernani G Golez, Ph. D. Director BPI’S ROLE IN BIOSAFETY REGULATIONS RISK ASSESSMENT...

Hernani G Golez, Ph. D.

Director

BPI’S ROLE IN BIOSAFETY

REGULATIONSRISK ASSESSMENT TRAINING-

WORKSHOPMay 24-28, 2004

Existing Biosafety Regulations (1)Executive Order No. 430

• Issued on October 15, 1990 Instituting the National Committee on Biosafety of the Philippines (NCBP)

• Task of formulating national policies and guidelines on biosafety

• BPI represents the Department of Agriculture in the institutional and individual composition of NCBP

Existing Biosafety Regulations (2)Department of Agriculture’s Administrative Order No. 8, Series of 2002

• Importation and Release into the

Environment of Plants and Plant

Products Derived from the Use of

Modern Biotechnology

Guiding Philosophies (1)We shall promote the safe and responsible use of modern biotechnology and its products as one of the means to achieve food security, equal access to health services, a sustainable and safe environment, and industry development.

Pres. Gloria M Arroyo

July 16, 2001

• Accelerate agricultural development, Accelerate agricultural development,

enhance production, and diversify products enhance production, and diversify products

for food security and global for food security and global

competitiveness competitiveness

• Safe and responsible use of modern Safe and responsible use of modern

biotechnology could increase farm yield, biotechnology could increase farm yield,

improve quality of farm products, reduce improve quality of farm products, reduce

use of pesticides and other inputs, enhance use of pesticides and other inputs, enhance

the environment, and reduce the environment, and reduce

farmer/consumer exposure to pesticidesfarmer/consumer exposure to pesticides

Guiding Philosophies (2)

COVERAGE: Regulated Article Any plant which has been altered or produced

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

Any plant or plant product altered or

produced through the use of modern

biotechnology which may pose significant

risks to human health and the environment

based on available scientific and technical

information

COVERAGE: Regulated Article

TYPES OF PERMIT Permit to Import for Contained Use

Permit to Field Test

Permit for Propagation

Permit to Import for Direct Use as Food or Feed, or for Processing

General Flowchart

Laboratory Testing

Field Testing

Propagation/ Gen. Release/ Commercialization

Direct Use for Food, Feed or For Processing

-Importation

-Importation

-Supervision

-Importation

-Monitoring

-Importation

APPLICATION TO IMPORT FOR CONTAINED USE

NOAPPROVED

DENIEDWithin 15 days

from acceptance of application

Grace period of 60 days to correct defects

Applicant

BPI

Sufficient in Form &

Substance?

Process & evaluate within 5 days of receipt

YES

Submit:

• 3 copies of Application Form;• NCBP Letter of Endorsement

APPLICATION TO FIELD TEST

Applicant

BPI


Substance?

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


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


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 consultationNCBP

APPLICATION TO RELEASE FOR PROPAGATION

Applicant

BPI


Substance?

STRPFor evaluation on risk assessment



YESNO

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

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

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



BAFPS

FPA

BAI

If pest-protected plant

In all instances

If intended as feed




Applicant

APPROVED

DENIED

APPLICATION FOR IMPORTATION FOR

DIRECT USE

Submit:• 3 copies of Application Form• support documents (copy of PIS, & notification from

country of import in accordance w/ existing international agreements on GMOs)

NO


BPI


Substance?


Within 60 days of acceptance

For evaluation on risk assessment STRP


BAFPSShall submit report w/n 30 days

BAIShall submit report w/n 30 days

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

Applicant

If intended as food

If intended as feed


YES

PETITION FOR DELISTING

Petitioner

BPI

SatisfactoryRequirements?


YESNO

Submit:• 2 copies of Petition• published scientific

literature relied upon


STRP

For evaluation on risk assessment

For publication of petition

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


APPROVED

ADD’L DATA REQUIRED

DENIED

Advocacy

1. Capacity Building – risk assessment,

risk communication, risk management,

molecular biology, and molecular

techniques

2. Public Consultations-biosafety policies

and guidelines

Hernani G Golez, Ph. D. Director BPI’S ROLE IN BIOSAFETY REGULATIONS RISK ASSESSMENT...

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