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 rules and regulations.

Risk Assessment
PRINCIPLES

Carried out in scientific & transparent

manner; based on available scientific & technical information Lack of scientific knowledge or consensus not to be interpreted as indicating a particular level of risk, absence of risk, or acceptable risk

Risk Assessment
PRINCIPLES

To be carried out on a case-by-case

basis Identified characteristics of GMO and its use shall be compared to those of non-GMO from which it is derived and its use under the same conditions If new information becomes available, risk assessment shall be readdressed

RESPONSIBLE OFFICER (
QUALIFICATION: appointed by the applicant (head of the import or release of GMO into the environment) Highest ranking official

resident of the Philippines (or resident of the country where he/she is)

DUTIES: ensure that all appropriate measures are taken to prevent adverse (unfavorable) effects on human health and the environment
designate a duly authorized representative

TYPES OF PERMIT
Permit for contained use Permit for field test

Permit to propagate
Permit to import for direct use food, feed, or for processing

Policy on importation for contained use:

It must be duly authorized by the Bureau of Plant Industry (BPI) upon endorsement of National Committee on Biosafety of the Philippines (NCBP).

Policy on field testing :

Permit for field test must be secured from BPI;

Regulated article must have been tested under contained conditions in the Philippines.

Who can apply??

Any juridical person who has and will maintain control over the importation or release of the GMO. It may be:

Department or agencies of the Government of the Philippines University-based research institutions in the Philippines

Duly recognized international research organization based in the Philippines

Corporation registered with Securities and Exchange Commission (SEC) Cooperatives registered with Cooperative Development Authority (CDA)

 Bureau of Plant Industry - lead agency and single entry point for applications and issuance of permits Bureau of Agriculture and Fisheries Product Standards for food safety assessment Bureau of Animal Industry for feed safety assessment Fertilizer and Pesticide Authority - for the assessment of pest-protected plants

Responsible agencies for safety assessment and compliance:

Technical support to BPI:

Scientific and Technical Review Panel (STRP), a non-DA pool of experts
Accredited laboratories Outside experts

Submit: 5 copies of Application Form

Applicant
60 day grace period to correct defects
NO

support documents (technical dossier; copy of PIS; & BPI certification that reg.art. has undergone satisfactory field testing in the Phils.

BPI
5 day process/ evaluation period
Sufficient in Form & Substance? YES

90 day period

APPROVED

DENIED
Evaluation and risk assessment

STRP
BAFPS FPA BAI
Applicant
Shall publish PIS in 2 papers, & invite comments w/in 30-day pd.

In all instances

If pest-protected plant

30 day period

APPLICATION TO RELEASE FOR PROPAGATION

If intended as feed For conduct of public consultation