Required Report: Required - Public Distribution

Date: December 04, 2023
Report Number:

RP2023-0065

Report Name: Agricultural Biotechnology Annual
Country: Philippines
Post: Manila
Report Category: Biotechnology and Other New Production Technologies

Prepared By:

Florence Mojica-Sevilla

Approved By: Mark Hanzel
Report Highlights:
The Philippines has been a pioneer within Asia in adopting biotechnology crops, and recently approved
Bt cotton as the 4th genetically engineered (GE) crop cleared for commercial propagation after corn
(2002), rice (2021), and eggplant (2022). The Philippines ranked 12th among the 29 countries in theworld that planted biotech crops in 2019. In 2022, area planted with biotech corn reached 576,000
hectares. The Philippines is the first country in the world to approve Golden Rice for commercial
propagation. Moreover, it is first in Southeast Asia to issue regulatory frameworks on geneticallyengineered (GE) crops for cultivation and passed a regulation for plants and plant products derived fromthe use of plant breeding innovations (PBIs), also referred to as New Plant Breeding Techniques(NBTs). The draft policy and regulations on animal biotechnology are under review and targeted forrelease before the end of 2023 or early in 2024.

THIS REPORT CONTAINS ASSESSMENTS OF COMMODITY AND TRADE ISSUES MADE BY USDA STAFF AND NOT NECESSARILYSTATEMENTS OF OFFICIAL U.S. GOVERNMENT POLICYEXECUTIVE SUMMARY
The Philippines continues to be a leader on biotechnology in Southeast Asia, having been the first in theregion to have a regulatory framework on genetically engineered (GE) crops. Corn, rice, eggplant, andcotton are GE crops currently allowed for commercial propagation. The biosafety permit for commercial
propagation of Bt cotton was issued on August 24, 2023, making it the 4th GE crop approved forcommercial propagation after corn (2002), rice (2021), and eggplant (2022). Planting of Bt eggplant andgolden rice continues while the GE corn area planted has increased from 10,700 hectares in 2003 to
576,000 hectares as of February 2023.
The country is moving forward with the implementation of three regulations: 1) revised Joint
Department Circular (JDC1); 2) Department of Agriculture (DA) Memorandum Circular (MC) No. 8,
which provides the regulatory policy for importation, handling and use, transboundary movement,
release into the environment, and management of GE plants and plants products derived from the use ofmodern biotechnology; and 3) the National Committee on Biosafety of the Philippines NCBP
Resolution No. 1, or, “the Regulation of Plant and Plant Products Derived from the Use of Plant
Breeding Innovations (PBIs) or New Plant Breeding Techniques (NBTs).” This regulation covers plants
and plant products derived from PBI/NBTs and provides guidance for determining whether or not a
specific plant should be regulated as a GE crop.
The revised JDC generally streamlined approvals by cutting the number of days for processing anapplication from 85 days to a maximum of 40 working days, while PBI/NBT regulation determination
was shortened to 32 days, with both processes brought into compliance with the Ease of Doing Businesslaw. An additional highlight is the formation of a Joint Assessment Group (JAG) to evaluate
applications for field trials, commercial propagation, and direct use.
The Philippines has drafted a regulatory policy for GE animals, which is applicable to the following: 1)
genetically engineered fish and other aquatic resources; 2) domesticated animals and biological products
used for animal husbandry for veterinary purposes; and 3) biological agents used for biocontrol derived
from the use of modern biotechnology and containing novel combinations of genetic materials. Productsof gene editing that do not contain novel combinations of genetic materials are not covered.
The Philippines was the eighth-largest market for U.S. agricultural and related products in 2022 with
exports reaching $4.1 billion, up 17 percent from 2021. The country continues to be the largest U.S.
soybean meal market, with $1.15 billion in sales in 2022.
For more information, please see the following GAIN reports:
GAIN Agricultural Biotechnology Annual 2022
Philippines First in World to Approve Golden Rice for Propagation
Philippines Streamlines Biotechnology Regulations with Revised Joint Department Circular
Genome Edited Plant Regulations Published
FAIRS Annual Country Report2

TABLE OF CONTENTS

CHAPTER 1: PLANT BIOTECHNOLOGYPART A: Production, and Trade ..................................................................................................... 4
PART B: Policy .............................................................................................................................. 9PART C: Marketing ........................................................................................................................22
CHAPTER 2: ANIMAL BIOTECHNOLOGYPART D: Production, and Trade .....................................................................................................24
PART E: Policy...............................................................................................................................24
PART F: Marketing ........................................................................................................................26
CHAPTER 3: MICROBIAL BIOTECHNOLOGYPART G: Production, and Trade .....................................................................................................27
PART H: Policy ..............................................................................................................................27
PART I: Marketing .........................................................................................................................28

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CHAPTER 1: PLANT BIOTECHNOLOGYThe Philippines uses biotechnology as one tool to reach its food security goals, and to modernize its
food systems to meet the United Nations Sustainable Development Goal number 2 of zero hunger by
2030. Agricultural biotechnology covers a range of tools, including traditional breeding techniques, tomake or modify products, improve plants or animals, or develop microorganisms for specificagricultural uses. Modern biotechnology today includes the tools of genetic engineering.
The country remains as the biotechnology leader in Asia, being the first to allow the planting of Bt cornand being the first to set up a regulatory framework for genetically engineered (GE) crops. In 2019, thePhilippines ranked 12th among the 29 countries in the world planting biotech crops (ISAAA, 2022). It isalso the first in the world to approve Golden Rice. Research and development (R&D) continue on otherpotential GE crops, and the country is moving towards developing GE animals.
PART A: PRODUCTION AND TRADEa) RESEARCH AND PRODUCT DEVELOPMENT:
GE products being developed include Papaya Ringspot Virus-Resistant (PRSV-R) papaya, and Multiple
Virus Resistant (MVR) tomato.
Papaya. The University of the Philippines Los Baños – Institute of Plant Breeding (UPLB-IPB)
developed PRSV-R Papaya with funding from the Department of Science, and Technology – Philippine
Council for Agriculture, Aquatic, and Natural Resources Research, and Development (DOSTPCAARRD), and support from USAID. It completed its first field trial in 2014, and a second field trial
in 2017. Preparations for further trials are underway.
Tomato. The MVR tomato is still being studied. UPLB has started on cutting-edge CRISPR research,and screening for viral disease resistance under the Fulbright Scholarship Program of the United States.
The tomato research will be continued in the Philippines with support from USDA’s Agricultural
Research Service and Foreign Agricultural Service.
Discussion on research on GE sugarcane is underway and is being considered for future research.
b) COMMERCIAL PRODUCTION: The Philippines recently approved its fourth GE crop, Bt
cotton, making it the 4th GE crop approved for commercial propagation after corn (2002), rice (2021),
and eggplant (2022). Bt eggplant has just launched while the rollout of Golden Rice commenced
following its approval in 2021. GE corn was approved for commercial propagation in 2002.
Cotton. On August 24, 2023, the Bureau of Plant Industry (BPI) issued a Biosafety Permit for thecommercial propagation of Bt cotton developed by the Philippine Fiber Industry Development Authority(PhilFIDA). Bt cotton replaces the need to control the bollworm through the application of synthetic
chemical pesticides harmful to human health and the environment.
Bt cotton is resistant to bollworm (Heliothis armigera), as it contains the Bt fusion gene GFM Cry1A,
synthesized based on the protein template of Cry 1Ab and Cry 1Ac protein. Bt cotton includes a gene4

taken from the soil bacterium Bacillus thuringiensis (Bt), which was also introduced in corn andeggplant in the Philippines. Field trials have shown more harvestable bolls and reduction in pesticides
application.
The PhilFIDA has conducted multi-locational field trials in Luzon and Mindanao with promising results.
Bt cotton could yield 3 tons per hectare compared with 1-2 tons using present local varieties. Bt cotton
cam address the issue of pests, increase yields, and deliver higher profits for farmers. Paired with thedevelopment of Bt cotton will be the promotion of heirloom and organic cotton production technology.
PhilFIDA collaborates with the Department of Trade and Industry to revive the industry to supply the
local weavers with locally produced cotton.
Figure 1. State of Biotechnology in the Philippines

Source: ISAAA
Eggplant. On October 18, 2022, the Philippines cleared Bt eggplant as its third GE approved forcommercial propagation following Bt corn and Golden Rice. Bt eggplant contains a natural protein fromthe soil bacterium called Bacillus thuringiensis, which makes it resistant to eggplant fruit and shootborer (EFSB). This Bt protein is targeted to EFSB and is safe for humans, animals, and other non-target
insects. Various scientific studies also showed that Bt eggplant is safe for the environment when planted
in open fields and can be an integral component of an Integrated Pest Management program. Reduction
on the use of insecticides lowers production costs and provides more income to farmers.

5

The Bureau of Plant Industry (BPI) issued a biosafety permit for direct use for food, feed, or processingfor Bt Eggplant on July 21, 2021, determining it safe for consumption. The University of the Philippines
Los Banos - Institute of Plant Breeding (UPLB-IPB) conducted the research on Bt Eggplant to address
the major pest known as eggplant fruit and shoot borer.
Figure 2

Source: FAS Manila compiled from various sources.
Rice. On July 21, 2021, the Philippines approved Golden Rice for commercial propagation. On March
18, 2021 DA issued Memorandum Order 19 Series of 2021 operationalizing the Department’s full
support for the deployment of Golden Rice. The Department, through its attached agencies, bureaus, andregional operations extends technical and logistical support to the DA-PhilRice in facilitating seedproduction, distribution, training, and communication.
On April 2022, Golden Rice with PSB Rc 82 background was registered with the National Seed Industry
Council (NSIC) as NSIC 2022 Rc 682GR2E or Malusog 1. The Bureau of Plant Industry – National
Seed Quality Control Services (BPI-NSQCS) finalizes the seed certification guidelines for geneticallymodified rice such as Golden Rice. Spearheaded by the Philippine Rice Research Institute (PhilRice) in
partnership with the International Rice Research Institute (IRRI), the beta-carotene enriched rice aims to
reduce vitamin A deficiency. The human body converts beta carotene into vitamin A, which isparticularly relevant for impoverished populations who rely on rice for their daily meals. The Bill andMelinda Gates Foundation, the Rockefeller Foundation, United States Agency for International
Development (USAID), and the Philippine Department of Agriculture - Biotechnology Program Office(DA-BPO) supported the golden rice project.

6

Figure 3

Source: FAS Manila compiled from various sources.
Corn. The development of GE corn started in 1996 under a collaborative study of UPLB-IPB and
Pioneer Overseas Corporation. Since the approval of the first GE corn for propagation in 2002, morecorn transformation events were developed by various companies and given biosafety permits. On July27, 2023, the BPI issued the updated list of GE corn events approved for commercial propagation. This
is to ensure that proper product stewardship of GM corn and other relevant policies are strictly compliedwith by all parties concerned. The BPI conducts regular monitoring, and any non-compliance with theexisting rules and regulations is dealt with accordingly. The BPI released the only approved GM corn
seeds with the corresponding permit holder and licensees to corn dealers. There are two general traits
developed for yellow corn: 1) insect resistance (Bt), which protects corn from pests, especially the
Asiatic Corn Borer; and 2) herbicide tolerance, which allows the use of a single (instead of multiple)
broad spectrum herbicide. Since the approval of Bt corn, and Roundup Ready (RR) or herbicide tolerant(HT) corn, companies also developed GE corn with stacked traits (Bt + HT), and the area planted with
GE corn grew rapidly. GE corn area increased from 10,769 hectares in 2003 to 576,000 hectares as ofFebruary 2023. The growth is an indication of increasing acceptance of using GE corn. The 2021
acreage dropped from 2019’s high and may be explained by logistical challenges during the Covid-19
pandemic. Currently, nearly all planted GE corn has stacked traits.
Fall armyworm or FAW (Spodoptera grugiperda) has been detected across the region. It was foundthree years ago in the Cagayan Valley region, and has since spread throughout the country, according to
DA.
On March 31, 2021, the DA issued Memorandum Order 26, establishing the Fall Armyworm
Management Project. It entails the conduct of pest monitoring and surveillance and the distribution ofinterventions in managing FAW incidences in corn production areas. The direct interventions include
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the distribution of pheromone lures, pesticides, power sprayers, ICT equipment, and pest awarenessmaterials.
Figure 4: Philippine GE Corn Planted Area
In ‘000 Hectares
900

800

700

In '000 Hectares

600

500

400

300

200

100

Bt/Ht
Ht
Bt

2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022*
576
602
678
819
627
552
653
649
602
560
687
649
494
232
215
71
5
5
3
15
31
7
3
7
86
168
21
15
9
47
51
120
26
22
21
40
48
82
123
97
50
60
11

Note: *As of February 2023 only.
Source: DA-BPO
a) EXPORTS: The Philippines exports no GE crops. The Philippines prohibits corn exports,
although a local industry association has asked the government to lift the restriction when local cornprices are down.
b) IMPORTS: The Philippines imports a variety of GE crops with approvals for direct use
including soybean, corn, cotton, canola, potato, rice, eggplant, and alfalfa. Refer here for the status ofapplications for direct use.
The Philippines was the eighth largest market for U.S. agricultural and related products with exports
reaching $4.1 billion in 2022, up 16 percent from 2021. The country continues to be the largest U.S.
soybean meal market (all of which is GE), with $1.15 million in sales in 2022. Philippine regulations
require shipments of various imported plant, and plant products to be accompanied by a “Declaration of“GMO” Content” signed by one of the following: the responsible officer from the originating country,
an accredited laboratory, the shipper, or the importer.

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In August of 2021, BPI issued
guidelines updating the list ofcommodities requiring the “GM”
declaration, expanding to moreproducts beyond bulk
commodities. Importers remain
authorized to sign the
Declaration of “GMO” Content.

Figure 5: Sample Form – Declaration of “GMO” Contentc) FOOD AID: The
Philippines is a consistent foodaid recipient through the USDA
Food for Progress program (e.g.,
GE soybean meal). The
importation of food aid
commodities has been
unimpeded by GE issues.
Source: DAd) TRADE BARRIERS:
Delays in the processing of
biosafety permits have the most potential to disrupt U.S. exports of GE product, although there havebeen no trade disruptions so far on food and related products. One notable issue has been on cotton
imports. It was only recently when BPI approved the removal of baled cotton in the list of commodities
that require GMO declaration. Prior, Philippine cotton importers claimed that it is difficult to provide the
Declaration of “GMO” Content due to the multiple sources of cotton in a single bale.
PART B: POLICYa) REGULATORY FRAMEWORK: The Philippines continues to be a leader in biotechnology inSoutheast Asia. It was the first in the region to have a regulatory framework for GE crops, the first in
Asia to approve cultivation of a GE crop for food and feed, and the first in the world to approve Golden
Rice for cultivation.
Table 1: Biotechnology Policy and Regulation
Legal Term
Legal Term
Laws and(in official(in English)
Regulations wherelanguage)
the term is used
“Genetically“Genetically
Joint Department
modified organism modified
Circular (JDC) No.1,(GMO”
organism
Series of 2021
(GMO)”
Department ofAgriculture (DA)
Memorandum
Circular (MC) No. 8,
Series of 2022

Legal Definition(in English)“living modified organism” under
the Cartagena Protocol on Biosafety
and refers to any living organismthat possess a novel combination ofgenetic material obtained throughthe use modern biotechnology

9Modernbiotechnology

ModernBiotechnology

National Committee
on Biosafety of thePhilippines (NCBP)
Resolution No. 1,
Series of 2020
JDC No.1, Series of2021
DA MC No. 8
NCBP Resolution
No. 1, Series of 2020

Plant Breeding
Innovations

New Plant
Breeding
Techniques

Novel
Combination

Novel
combination

Plant-incorporated
protectant (PIP)

Plantincorporated
protectant (PIP)

Regulated article

Regulated
articleResponsible
officer

Responsible
officerJDC No.1, Series of2021
DA MC No. 8
NCBP Resolution
No. 1, Series of 2020
JDC No.1, Series of2021
DA MC No. 8
NCBP Resolution
No. 1, Series of 2020
JDC No.1, Series of
2021

JDC No.1, Series of2021
DA MC No. 8
JDC No.1, Series of2021

Refers to the application of: 1) invitro nucleic acid techniques,
including recombinant
deoxyribonucleic acid (DNA) or
direct injection of nucleic acid into
cells or organelles; or 2) fusion ofcells beyond the taxonomy family,that overcome natural physiologicalreproductive or recombination
barriers and that not techniques usedin traditional breeding or selection
If contains a novel combination ofgenetic material obtained throughmodern biotechnology

A resultant genetic combination in aliving organism that is not possible
through conventional breeding.

Refers to pesticidal substanceproduced by plants and genetic
material necessary for the plant toproduce the substance
Refers to genetically modified
plants and plant products under thescope of the JDC
Refers to an officer appointed by theapplicant for the importation orrelease into the environment of aregulate article who shall ensure that
all appropriate measures are taken toprevent significant risks to humanhealth and the environment. The
responsible officer shall be aresident of the Philippines and thehighest-ranking officers of theapplicant10

“Stacked events”“Stacked
events”“Transformation
event”“Transformation JDC No.1, Series of
event”2021

JDC No.1, Series of2021

Refer to “genetically modified”
plants and their products that havebeen developed using multiple
transformation events encoding
several proteins that confer specifictraitsRefers to the uptake and integrationof specific sequences of DNA in the
genome of the host organism inwhich the introduced DNA isintended to change the phenotype ofthe recipient organism in a
predictable manner

In 1990, Executive Order (EO) 430 created the National Committee on Biosafety of the Philippines(NCBP), tasked to formulate, review, and amend national policy on biosafety, and formulate guidelines
on the conduct of activities on genetic engineering. EO 514 further strengthened the committee’s workby establishing the National Biosafety Framework, prescribing guidelines for its implementation, andstrengthening the NCBP chaired by the DOST Secretary. It evolved with Administrative Order No. 1(AO 1) in 2019., and after the Supreme Court ruled that AO 8 was null and void in 2015, was replacedby the Joint Department Circular No. 1 (JDC) in 2016.
In February 2022, the Philippines approved the revised Joint Department Circular No. 1 (JDC1) signed
by Department of Science, and Technology (DOST), Department Agriculture (DA), Department ofEnvironment, and Natural Resource (DENR), Department of Health (DOH), and Department of Interior,and Local Government (DILG). JDC1 provides the regulatory policy for importation, handling and use,transboundary movement, release into the environment, and management of GE plants, and plant
products. The agencies involved reviewed and finalized the JDC to modernize and streamline theregulatory framework, taking note to comply with the Ease of Doing Business law.

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The revised JDC generally streamlined the process by: 1) removing irrelevant requirements or
redundant competent national authorities (CNA) roles; 2) reducing the required socio-economic
considerations and making local government unit (LGU) endorsement optional; 3) improving text
clarity (i.e. pertaining to Food, Feed, Processing applications; 4) introducing text relating to“transportability” of GE approvals from other countries; 5) deregulating GE crops after five years ofrecord of safe use (commercial propagation, and FFP) and biosafety permits will remain valid unless
revoked; 6) cutting the days to process an application from 85 days to a maximum of 40 working days incompliance with the Ease of Doing Business law or RA 11032, and any extensions of the time frame
will have to be applied, and approved by the Anti-Red Tape Authority; 7) no longer requiring stacked
GE plants and derived products to have a separate approval if their single event components alreadyhave existing biosafety
permits. An additional
Figure 6. Timeline for Processing of Biosafety Applications
highlight is the formation of a
Joint Assessment Group (JAG)
to evaluate applications forfield trial, commercial
propagation, and direct use.
This shortens the process,where before the different
biosafety committees of thefour Departments did theirassessments independently.
The above reforms shorten thewait for approvals andprocesses drastically and are
expected to greatly reducecompliance costs and lower thebarriers to commercializing
biotech crops.
Source: DOST-NCBP
Table 2: Institutions in Crop Biotechnology Policy
Regulations
Risk assessments, and registrations
NCBP - mandated to formulate, review,
DENR - conducts risk assessment for impact ofamend the biosafety guidelines.
biotech crops on the environment
DOST-Biosafety Committee - processes
DOH - conducts risk assessment for the impact ofapplications for Contained use, and Confined biotech crops as food on human health
Test, and issues Certificates of Completion.
DA-BPI, and DA-BC - consolidate and
DA-Bureau of Animal Industry (BAI) - conducts risk
evaluate the risk assessment reports.
assessment for the impact of biotech crops as feed on
The BPI Director issues Biosafety Permit foranimals
applications for (Multi-location) Field Test,
DA-Fertilizer and Pesticides Authority (FPA) Commercial Propagation, and Direct Use forregistration of plant incorporated protectants (PIP)
food, feed, or processing
Source: JDC1

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Table 3: Role of National Government Agencies in the Safety Assessment of GE Crops
Department ofLead in addressing biosafety issues related to the country’s agricultural
Agriculture
productivity and food security. Lead in the evaluation, and monitoring of(DA)regulated articles.
Department of Science Lead in ensuring that the best science is utilized and applied in adopting
and Technology
biosafety policies, and in making biosafety decisions. Lead in evaluating and(DOST)
monitoring contained use of regulated articles.
Department of
Ensure that the applicable environmental assessments are undertaken, andEnvironment andpotential impacts identified. Lead in evaluating and monitoring
Natural Resourcebioremediation, improvement of genetic resources, and wildlife genetic(DENR)
resources.
Department of Health Formulate guidelines and review results of assessing the health impacts(DOH)
posed by modern biotechnology. Lead in evaluating and monitoringprocessed food derived from or containing “GMOs.”
Department of Interior Oversee implementation of the activities undertaken in specific LGUs inand Local
relation to the conduct of public consultations as required by the Local
Government (DILG)
Government Code.
Source: JDC1On September 24, 2021, the Philippine government created a Review Team on the implementation of
the JDC1 on the regulation of GE plant and plant products.
Under the JDC1, the DOST and DA lead the implementation of biosafety guidelines. The other agencies
involved are DOH, DENR, and DILG. Every stage of the research and development of GE crops isregulated until reaching the commercialization phase. For ease in compliance, the DOST published thesebiosafety guidelines.
GE crops developed locally and intended to be commercially grown in the Philippines must undergo
regulatory processes following the guidelines set forth under the JDC1. The process flow is presented
here. Only after a biosafety permit is issued with satisfactory completion and an approval of Commercial
Propagation application is granted can the GE crop be registered with the National Seed Industry
Council (NSIC). Under the Plant Variety Protection Act (PVPA), GE developers reserve the right togive exclusive contracts to seed companies for the multiplication and distribution of seeds to retailers
and ultimately sell to the farmers.
Compliance with Other Regulations
The Certificate of Non-Coverage from the JDC1 shall not excuse the product developer from complying
with other relevant regulations of the DA, and other government agencies, such as those involving
quarantine, pest risk analysis, varietal registration, and crop-specific standards and programs, where
warranted.
b) APPROVALS/AUTHORIZATIONS: The status of applications for direct use, field trial, andpropagation are listed on the DA Biotechnology website. On March 17, 2023, the Philippine Fiber
Industry Development Authority (PhilFIDA) submitted its application for biosafety permit forcommercial propagation of Bt cotton (GFM cry1A) under the Joint Department Circular No. 1 Series of13

2021 (JDC1) to the Bureau of Plant Industry (BPI). On March 20, 2023, BPI sent the acceptance to
PhilFIDA having completed the required documents. On April 20, 2023, BPI reviewed PhilFIDA’s
Public Information Sheet (PIS) and found it sufficient. In accordance with the JDC1, the Joint
Assessment Group (JAG) shall review the application within ten working days upon acceptance of theapplication. The JAG, however, required additional information for appropriate action by PhilFIDA,
which delayed the process. The JAG, composed of representatives from Department of Science andTechnology, Department of Agriculture, Department of Environment and Natural Resources andDepartment of Health, and Department of Agriculture-Biosafety Committee, required additional
information and needed more time.
In April 2023, the Philippines approved gene-edited reduced browning bananas. BPI has technicallyevaluated and determined gene-edited banana to be non-GE, and the first gene-edited product to go
through the Philippines’ gene editing regulatory process.
c) STACKED or PYRAMID EVENT APPROVALS/AUTHORIZATIONS: For GE Corn in thePhilippines, recent varieties generally have stacked traits, a combination of Bt (insect resistance) and HT(herbicide tolerance). Stacked event crops composed of approved individual events no longer need toreapply under the revised JDC1. This development continues the Philippines’ recent achievements inbiotech, having streamlined the overall regulatory framework for genetically engineered plant products
in January 2022 through the revised JDC1.

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Figure 7: Flow Chart for Application for Commercial Propagation (Single Event)

Source: DA-BPOd) FIELD TESTING: Below are the process and the regulatory institutions involved to conduct
field trial. A field trial to generate data for environmental biosafety risk assessment of Golden Rice wasconducted, and approved on May 20, 2019, the only field trial application so far under JDC 1.

15

Figure 8: Process Flow for Issuance of Certificate of Field Trial Completion

Source: DA-BPOe) INNOVATIVE BIOTECHNOLOGIES: The DA issued Memorandum Circular No. 8 pursuant
to the revised JDC1, which provides the regulatory policy for importation, handling and use,transboundary movement, release into the environment, and management of GE plants, and plants
products derived from the use of modern biotechnology, and the NCBP Resolution No. 1, or the
regulation of plant, and plant products derived from the use of Plant Breeding Innovations (PBIs) or
New Plant Breeding Techniques (NBTs). This regulation shall cover plants and plant products derived

16

from NBTs/PBIs to determine whether they should be regulated as GE crops. Defined under EO 514,
products from PBIs can be classified as a “GMO” if they contains a novel combination of genetic
material obtained through modern biotechnology. The NCBP defines a novel combination as a resultant
genetic combination in a living organism that is not possible through conventional breeding. Otherwise,a product is a “non-GMO” or conventional. The DA leads in evaluating and monitoring products of
PBIs, and determining when products derived from PBIs are GE, and therefore regulated under therevised JDC1. The circular sets the procedural requirement for the conduct of a Technical Consultation
for Evaluation and Determinations (TCED), which determines if a PBI is genetically engineered or not.
It will take 32 days to process the request submitted.
Figure 9: Timeline for Processing Request under DA MC 8

In a case when the PBI product isofficially determined as not GE, a
Certificate of Non-Coverage fromthe JDC1 shall be issued to the
product developer. The certificate
shall not excuse the productdeveloper from complying withother relevant regulations such as
those involving quarantine, pest risk
analysis, varietal registration, andcrop-specific standards andprograms.

Source: DOST-NCBP
Technical Consultation for Evaluation and Determination
A product developer who intends to introduce a PBI product into the country shall submit a request to
the Director of BPI for Technical Consultation for Evaluation, and Determination (TCED), which is atechnical evaluation of the PBI product to determine whether the final product of the plant breeding
process employed to produce the PBI product contains a novel combination of genetic material obtained
through the use of modern biotechnology.
In the case of projects to develop or obtain PBI products that are still at the product concept or R&D
phase, the product developer may file a request for TCED, in anticipation that the expected target
product falls under the scope and coverage of the JDC1 s2021. In such a case, the TCED Group may
perform a preliminary analysis, and provide an indicative answer that will be communicated by BPI to
the product developer. Upon the request of the product developer, portions of the submission may betreated as confidential information.

17

Figure 10: Decision Tree on the Regulation of Plant, and Plant Products Derived
from the Use of Plant Breeding Innovations

Source: DOST-NCBP
BPI Biotechnology Core Team (BPI-BCT) – Plant Breeding Innovation. Composed of qualified
technical staff from BPI and shall be chaired by the BPI Assistant Director for Regulatory Services.
•

For every officially accepted request, it shall form a Technical Consultation for Evaluation andDetermination (TCED) Group composed of three (3) members, with at least two (2) members
from the BCT-PBI selected based on availability, and the other member appointed by the Chairof the BCT-PBI as an external expert, if deemed necessary.

•

TCED Group shall be responsible for the conduct of the technical evaluation, and determinationon the regulatory status of the PBI product under the JDC1, s2021.

•

The BPI Director shall issue succeeding policy on the BCT-PBI on its composition, specificduties, and responsibilities in the implementation of this Circular.

18

Figure 11: Process Flow for the Conduct of Technical Consultation
for Evaluation, and Determination (TCED)

Source: DOST-NCBP
On April 4, 2023, the DA created the Department of Agriculture Biosafety Committee (DA-BC),chaired by the Director of the Bureau of Agriculture and Fisheries Standards (BAFS) and a
representative from UP-Diliman as Vice-Chair. Committee members are BAI, PhilFIDA, PhilRice,
UPLB, BPI, Fertilizer and Pesticide Authority (FPA), Food Development Center (FDC).
Researchers at the UPLB use innovative technologies to develop improved eggplant varieties that areresistant to eggplant fruit and shoot borer (EFSB), and leafhopper (LH) using genomics, IT-based
phenotyping platforms, molecular marker technologies, and new breeding techniques to fast-track thisdevelopment.
The Philippine Genome Center was launched in 2011 under the University of the Philippines system.
PGC is involved in a variety of genomics research, with agriculture projects including coconut, shrimp,
coffee, abaca, banana (saba), sugarcane, pili, and dairy cattle. Other focus areas are development of
diagnostic kits for identifying disease and genetic diversity of livestock, crops, forest trees, fish, andfood. UPLB research also support studies on these crops.
f) COEXISTENCE: There are no rules in place or proposed on coexistence. There are concerns
raised such as gene flow across plantation that may reach organic crops causing contamination, which
can lose status as organic products.

19g) LABELING, and TRACEABILITY: Currently there are no labeling requirements for GE foodproducts. The most recent GE labeling bill filed under the 18th Philippine Congress is House Bill 6411
known as “The Philippine “GMO” Labeling, and Regulation Act, The Right-to-Know Act,” which
would require labeling and regulation of food containing GE ingredients or derived from GE. There has
been little development since the 2020 report.
h) MONITORING, AND TESTING: The permit to propagate GE crops carries a stipulated
provision that requires the technology developer to undertake insect resistance management practices (ifthe approved event is Bt), and/or weed resistance interventions if the event involved is glyphosatetolerance. The monitoring and testing process follows the process as presented in the field trials above,and the below process for post-approval monitoring. Details on testing, monitoring, and reporting
requirements are included in the biosafety guidelines.
Figure 12: Flow Chart for Post Approval Monitoring

Source: DA-BPO
i) LOW LEVEL PRESENCE (LLP) POLICY: In early 2009, the DA approved Administrative
Order No. 1 (DA-AO No. 1) adopting Annex 3 of the Codex Plant Guideline i.e., “Food Safety

20Assessment in Situations of Low-Level Presence of Recombinant-DNA Plant Material in Food” for the
conduct of food safety assessment in situations of LLP of recombinant-DNA plant materials in food, andfeed. DA-AO No. 1 directs the DA Policy and Regulatory Office to clarify issues, and formulate
guidelines to implement the LLP policy. To date, no implementation guidelines have been issued, but
DA-BPO commissioned a third party who conducted a study on LLP. The study results are yet to bereleased.
j) ADDITIONAL REGULATORY REQUIREMENTS: In October 2020, all technology
developers filing GE applications were required to submit two studies to hasten the biosafety approval
process, and information on any changes in the product.
After an application is approved, seed registration is still required with the National Seed Industry
Council under BPI. On June 29, 2021, NSIC issued NSIC Resolution No. 5 or a resolution adopting aunified policy by NSIC on testing for variety registration of all “genetically modified” crops.
k) INTELLECTUAL PROPERTY RIGHTS (IPR): There are no plant patents in the Philippines.
The country achieved compliance with its obligations under the World Trade Organization Trade
Related Aspects of Intellectual Property Rights Agreement on June 11, 2007 with the passage ofRepublic Act 9168, otherwise known as the Plant Variety Protection Act of 2002 (PVPA).
Under the PVPA, holders of Plant Variety Protection certificates have the right to authorize theproduction, reproduction, export, and import of the varieties they have developed. These rights extend toharvested material from the unauthorized use of their protected varieties – except if the use is by small
farmers. Their rights also cover derived varieties (or those varieties predominantly derived from theinitial variety under protection). Provisional protection is provided to breeders, entitling them to someremuneration from the time the application is published until the granting of the certificate of PVP.
In cases of infringement, the holder of the PVP certificate may petition the regional trial court for relief.
As with other intellectual property rights laws, the local courts are relied on for enforcement. Under the
PVPA, farmers are accorded the traditional right to save, use, exchange, share, or sell their farm produceof a protected variety, except when the sale is for the purpose of reproduction under a commercial
marketing agreement. The exchange and sale of seeds among farmers is allowed on the condition thatthese are reproduced and replanted on their own lands.
l) CARTAGENA PROTOCOL RATIFICATION: The Philippine Senate on August 14, 2006
adopted Senate Resolution No. 92 or the “Resolution Concurring in the Ratification of the Cartagena
Protocol on Biosafety (CPB) to the UN Convention on Biological Diversity.” The CPB ratification
followed the March 2006 issuance of Executive Order No. 514, adopting the National Biosafety
Framework (NBF), which was the interim implementing mechanism of the CPB. The NCPB oversees
the implementation of the NBF and coordinates the implementation of decisions made under the
Conference of Parties serving as Meeting of Parties (COP-MOP) in fulfilling the country’s international
obligations as Party to the Cartagena Protocol on Biosafety.
m) INTERNATIONAL TREATIES, and FORUMS: The Philippines actively participates ininternational forums, including Codex Alimentarius as well as related activities of the Asia Pacific
Economic Cooperation (APEC).

21n) RELATED ISSUES: Additional information, and updates on related issues can be accessed on
the DA’s biotech website.
The Nagoya-Kuala Lumpur Supplementary Protocol on Liability, and Redress (NKLSP), which was
finalized in 2010 and put into force in 2018, has not been ratified in the Philippines, despite the country
being one of the negotiators. In 2016, the NCBP Technical Working Group (TWG) assessed thecountry's preparedness in implementing the NKLSP and tackled existing laws and policies that would
address the damage. Key findings indicated the lack of a unified operational definition of damage tobiological diversity. Furthermore, the administrative nature of the NKLSP would require an agency
authorized for its implementation.
PART C: MARKETINGa) PUBLIC/PRIVATE OPINIONS: A study on Public Perception on Agribiotechnology was
published by ISAAA on May 2023. Study findings revealed that Filipino stakeholders in general aresupportive of biotechnology in crop production and consider it as beneficial to society in terms of foodand medicines. Scientists are the most trusted sources of information but are ironically not thataccessible and visible in the community. Social media, even if not highly trusted, is influential because itis the most accessible and omnipresent in many areas. After almost 16 years from the previous
perception study, improvement of perception occurred in the following areas: (a) biotech information as
being more useful, of better quality and better understood; (b) biotechnology regulations as protective of
public safety and health, (c) higher motivation to join biotech-related activities that do not involve muchof their time and money, and (d) more emphasis on end uses of biotechnology as food and medicines as
primary consideration in making decisions about biotechnology.
A comparison of biotech perception between “GMO” and “Non-GMO” provinces was also conducted.
“Non-GMO” areas covered three provinces where GMOs are not allowed entry by virtue of a provincial
resolution. They are Oriental Mindoro, Negros Occidental, and North Cotabato. Study results revealed
that there were overwhelming similarities among respondents in “GMO” and “non-GMO” areas. In fact,
being in an area where “GMO” was banned had no effect at all on the public’s perception and attitude
towards biotech. Ironically, those from “non-GMO” areas showed better knowledge on biotech in foodproduction than those from “GMO” areas. More stakeholders in the “non-GMO" areas were also more
optimistic and interested in biotech and fewer stakeholders regarded biotech as being hazardous.
On April 18, 2023, the Supreme Court issued a writ of kalikasan on Golden Rice and Bt Eggplant. The
petition filed on October 12, 2022, sought to stop the commercial release of the recently approved Bt
Eggplant and stop the progress of Golden Rice. This is a repeat of the much-publicized Supreme Court
ruling in December 2015, as well as the JDC public consultations in 2016, brought the GE debate into
the public realm. Many policy makers, including Philippine legislators and members of the judiciary,
have expressed increased interest in obtaining current information on GE crops and products.
Support for GE products remains strong among local corn farmers, hog and poultry raisers, feed millers,
food processors, academics, and other end users. Although supportive, large domestic food andagribusiness companies that are already using GE products prefer to remain silent on the issue. On theother hand, non-governmental organizations (NGOs), including environmental groups, organic

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agriculture advocates, and other civil society groups represent vocal opposition to agricultural
biotechnology. There are also local government ordinances banning GE crops and products. The
majority of Filipinos, however, remain indifferent.
b) MARKET ACCEPTANCE/STUDIES: Despite the established safety of GE products, increased
market acceptance is dampened by the misinformation campaign by anti-GE advocates. One indicator ofmarket acceptance, however, is the growth in GE corn area from just 10.7 hectares planted in 2003 to
576,000 hectares in 2023.
One Singapore-based research group in 2021 found that many Filipino consumers are unaware of what
GE products are in the market and unsure if they are consuming them. The study noted a plurality of
consumers (33 percent) were undecided as to whether they would consider GE foods in the future,compared to 21 percent very likely/likely, and 41 percent who responded they were very
unlikely/unlikely.
In 2009, students from the Asian Institute of Management conducted market research on Golden Rice toidentify attitudes and perceptions pertaining to diet and nutrition. Their research presentation found thatin general, despite the different color and being a GE crop, results showed high acceptability for Golden
Rice, but also noted respondents had little knowledge on several key factors such as those pertaining to
genetically engineered crops, vitamin A deficiency, and proper nutrition.

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CHAPTER 2: ANIMAL BIOTECHNOLOGYPART D: PRODUCTION, AND TRADEa) RESEARCH, AND PRODUCT DEVELOPMENT: According to the Livestock Biotechnology
Center (LBC) artificial insemination (AI) is the most widely applied animal biotechnology, particularly
in combination with cryopreservation, allowing significant genetic improvement for productivity withother technologies such as monitoring reproductive hormones, oestrus synchronization, and semen
sexing for AI efficiency.
The Philippine Carabao Center adopts the somatic cell nuclear transfer technology, complementing
other existing reproductive tools for buffaloes to develop/optimize a system for cloning through somatic
cell nuclear transfer. Buffalo clone embryos have been successfully produced in-vitro.
There are no GE or genome-edited animals or clones under development. LBC notes that animal
biotechnologies in the Philippines are in the development of rapid animal disease test kits, reproductive
biotechnologies, and product development. Research on heat tolerant livestock is being studied.
The Philippines is still at the stage of DNA barcoding for livestock and poultry. The UPLB College ofAgriculture and Food Science did a study on genotyping dairy cattle but stopped at Phase 1.
b) COMMERCIAL PRODUCTION: Not applicable.
c) EXPORTS: Not applicable.
d) IMPORTS: Not applicable.
e) TRADE BARRIERS: There are no biotechnology-related trade barriers that negatively affect
U.S. animal biotechnology exports.
PART E: POLICYa) REGULATORY FRAMEWORK: The Philippines has drafted the regulatory framework for GE
animals, including insects. The finalization of the policy regulations has been stalled on issues over the
responsible agency that should cover mosquitos. The DA cannot cover mosquitoes, as they are neither
food nor feed. The responsible agency could either be the Department of Environment and Natural
Resources or the Department of Health. Mosquitoes have therefore been excluded and the regulatory
framework is focused on agricultural animals. The GE animal regulatory policy is applicable to thefollowing: 1) genetically engineered fisheries, and other aquatic resources; 2) domesticated animals, andbiological products used for animal husbandry for veterinary purposes; and 3) biological agents used forbiocontrol derived from the use of modern biotechnology and containing novel combinations of genetic
materials. Products of gene editing that do not contain novel combinations of genetic materials are notcovered.

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The biosafety decision considers the following areas: 1) transparency, and public participation; 2) accessto information; 3) socio-economic, ethical, and cultural considerations; 4) standard precaution; 5) risk
assessment; and 6) environmental, and health risk assessment.
The draft JDC on “GM” Animals follows the below general procedure:
Figure 13: General Procedure for Regulated Articles for Commercial Use

Source: Mingala, Claro, DA-BPO
b) APPROVALS/AUTHORIZATIONS: Not applicable.
c) INNOVATIVE BIOTECHNOLOGIES: Animal products are not covered in the development ofregulations for plant products of genome editing (i.e., NCBP Resolution No. 1, Series of 2020). Animals
made with innovative biotechnologies would likely need to be covered by a separate policy.
d) LABELING, and TRACEABILITY: Not applicable.
e) ADDITIONAL REGULATORY REQUIREMENTS: Not applicable.
f) INTELLECTUAL PROPERTY RIGHTS (IPR): Not applicable.
g) INTERNATIONAL TREATIES, and FORUMS: The Philippines is a member of the Codex
Alimentarius, and the World Organization of Animal Health, and joins the discussions on agricultural
biotechnology.

25h) RELATED ISSUES: The DA’s Livestock Biotechnology Center opened in 2014, andcoordinates and monitors livestock biotechnology research and development in the Philippines.
PART F: MARKETINGa) PUBLIC/PRIVATE OPINIONS: Public awareness of GE animals is low. According to a reportby a study group contracted by the DA, the regulatory issues associated with transgenic animals include
food safety, environmental safety, ethical concerns, such as animal welfare, product efficacy, andeffectiveness, and socioeconomics. Conducting webinars/seminars increases awareness, and it isexpected to widen once the series of consultations are undertaken to finalize the regulatory framework
for GE animals.
Based on the study on Public Perception on Agribiotechnology published by ISAAA on May 2023,
Filipino stakeholders in general are supportive of biotechnology in crop production, but
support is not as solid in terms of biotech in animal production. There was a perceived lack ofknowledge about animal biotechnology. There was a certain level of reservation to support thetechnology. Study results revealed that stakeholders believed that some valid reservations remain
depending on how the technology affects people and the environment over time. Grounds for having
reservations about animal biotechnology were respect for animal rights and welfare, presence of
unknown risks, interfering with nature, and religious grounds, among others.
According to a report by a study group contracted by the DA, the regulatory issues associated withtransgenic animals include food safety, environmental safety, ethical concerns, such as animal welfare,
product efficacy, and effectiveness, and socioeconomics. Conducting webinars/seminars increases
awareness, and it is expected to widen once the series of consultations are undertaken to finalize theregulatory framework for GE animals.
b) MARKET ACCEPTANCE/STUDIES: Not applicable.

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CHAPTER 3: MICROBIAL BIOTECHNOLOGYPART G: PRODUCTION, AND TRADEa) COMMERCIAL PRODUCTION: No information is available regarding whether the Philippines
produces food or food ingredients derived from microbial biotechnology.
b) EXPORTS: Not applicable.
c) IMPORTS: Not applicable.
d) TRADE BARRIERS: Not applicable.
PART H: POLICYa) REGULATORY FRAMEWORK: The Philippines currently does not have a regulatory process
for the commercial production, use, and trade of biotech-derived microbes or microbial biotech-derived
food and food ingredients. Post is not aware of any discussions pertaining to the drafting of regulation ortrade policies on microbial biotech.
Executive Order No. 514, Series of 2006 established the National Biosafety Framework, and does not
mention GE microbes or how they would be regulated. However, EO 514 does specify that all research,and development applications, regardless of life form or intended use, shall be regulated by the
Department of Science and Technology Biosafety Committee. There have been previous experiments
using GE microorganisms, as noted here.
The Philippine Biosafety Guidelines for Contained Use of Genetically Modified Organisms (“GMO”s),
Revised Edition, September 2014, stipulates that the guidelines will apply to all biotech applications
under “contained use (i.e. laboratory, screen house, glasshouse, greenhouse) and confined test.” The
guidelines cover plants/crops, pharmaceutical plants, animals, forest trees, and microorganisms. The fullguidelines can be found here. The policy and procedures to apply for a contained use experiment ofbiotech microbes are listed on page 56 of the Biosafety Guidelines.
a) REGULATORY FRAMEWORK: Not applicableb) APPROVALS/AUTHORIZATIONS: Not applicable.
c) LABELING, and TRACEABILITY: Not applicable.
d) MONITORING, AND TESTING: Not applicable.
e) ADDITIONAL REGULATORY REQUIREMENTS: Not applicable.
f) INTELLECTUAL PROPERTY RIGHTS (IPR): Not applicable.

27g) RELATED ISSUES: Not applicable.
PART I: MARKETINGa) PUBLIC/PRIVATE OPINIONS: Public awareness of microbial biotech is very low.
b) MARKET ACCEPTANCE/STUDIES: Not applicable

Attachments:
No Attachments

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