Regulatory Status of Gene Editing: Philippines by Saturnina C Halos during the Regional Expert Consultation on Gene Editing in Agriculture and its Regulations Technical Session II

1. Regulatory Status of Gene Editing: Philippines
Presented by Saturnina C Halos, PhD, Regional Expert Consultation on Gene Editing in Agriculture and its Regulation
Date: October 10-11, 2019 International Crop Research Institute for the Semi-Arid Tropics, Patancheru, Hyderabad, India

2. Biotechnology regulation in the Philippines
Activities on regulation of NBT and its products

3. Biotechnology regulation
Executive Order 430 ser 1990
created the National Committee on Biosafety of the Philippines (NCBP),
NCBP functions: formulate, review and amend national policy on
biosafety & formulate guidelines on biosafety implementation
Composition: one representative each
Department of Agriculture (DA);
Department of Environment and Natural Resources (DENR);
Department of Health (DOH) &
Department of Science and Technology (DOST),
one scientist each: biology, environmental science, social science
physical science;
2 respected members of the community.
Focus of regulation: genetic engineering and its products

4. Dept of Agriculture Administrative Order No 8 ser 2002 (DA AO 8)
– implementing guidelines for importation and release into the environment
of plant and plant products derived from modern biotechnology
Allowed for the import of seeds & commodities derived from genetically
engineered plants and the commercial production of Bt/RR corn since 2003

5. Executive Order No.514 ser 2006
established the National Biosafety Framework
National Biosafety Framework
prescribed guidelines for its implementation
reorganized the National Committee on Biosafety of the
Philippines (NCBP)
defined the roles of various agencies in implementing biosafety
Focus of regulation - LMOs as defined by the Cartagena
Protocol on Biosafety

6. December 8, 2015 - Philippine Supreme Court declared DA AO8 null and void,
regulatory system not conforming to the National Biosafety Framework,
= all activities on genetic engineering temporarily stopped
In response – Joint Department Circular No 1 ser 2016 (JDC 1) was issued by
Departments of Agriculture (DA), Science & Technology (DOST),
Environment and Natural Resources (DENR), Health (DOH), and
Interior & Local Government (DILG)
“Rules and Regulations for the Research and Development, Handling and
Use, Transboundary Movement, Release into the Environment, and
Management of Genetically-Modified Plant and Plant Products Derived
from the Use of Modern Biotechnology”
July 26, 2016 Philippine Supreme Court reversed its decision of Dec 8, 2015
but recognized JDC 1

7. Regulation of NBT under JDC 1
NBT – New Breeding Techniques :
Site-directed nucleases (Genome/gene editing), Cisgenesis & intragenesis,
RNA-directed DNA methylation, reverse breeding, Synthetic genomics,
Agroinfiltration/agroinoculation, Grafting with GM material, Cell Fusion
Discussions on NBT started 2014 – DA AO 8 regime
Expert review of NBT and its global regulation and recommendations for
regulation ( Dept of Agriculture, Biotechnology Program, 2018),
Review & recommendations endorsed to the NCBP – 2019
Symposium on Risk Assessment of Plants Developed Using New Breeding
Technologies (ILSI/BPI/BCP) – Oct 8-9, 2019 Alabang, Philippines
NCBP – formed technical committee to draft guidelines on NBT
regulation, compliant to JDC1, regulation of LMOs, 2019

8. Thank you