DECEMBER 2021

DISCUSSION PAPER SERIES NO. 2021-45

Modern Biotechnology Application and Regulation

in the Philippines: Issues and Prospects

Sonny N. Domingo and Arvie Joy A. Manejar

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Modern Biotechnology Application and Regulation in the
Philippines: Issues and Prospects

Sonny N. Domingo
Arvie Joy A. Manejar

PHILIPPINE INSTITUTE FOR DEVELOPMENT STUDIES

December 2021
Abstract

Modern crop biotechnology is being considered as a novel solution to the long-standing

problems of food insecurity, low crop productivity, pest and disease prevalence, and
micronutrient deficiency, particularly in developing and climate-vulnerable economies.
Empirical evidence of its benefits encouraged the development and adoption of genetically
modified organisms (GMOs) and related products, fostering global market dynamism. The
Philippines’ early adoption of technology and its inclusion among countries with highest GMO
corn hectarage in early 2000s motivated the creation of regulatory guidelines and biosafety
policies which informed development and commercialization timelines. The study reviewed
the enabling regulatory structures to determine entry points for augmentation while an
economic surplus analysis of GMO eggplant was carried out as case study to estimate welfare
benefits and potential opportunity costs for both consumers and local growers. Results showed
that across simulations, even with the most conservative adoption delays due to regulatory lags,
viable figures were still obtained with the lowest IRR at 20 percent. Notwithstanding contrary
sentiments from interest groups, the government’s priority must be to make available the
modern biotechnology option, in both farm and household table, in the most prudent but
expedient way possible. The huge opportunity losses attached to suboptimal bureaucratic
regulatory functioning have to be stemmed.

Keywords: biotechnology, modified crops, GMOs, regulatory process

i
 Table of Contents
1. Introduction ........................................................................................................... 1
1.1. Background of the study ...................................................................................... 1
1.2. Objectives ............................................................................................................ 2
1.3. Policy questions ................................................................................................... 2
2. National landscape ................................................................................................ 2
2.1. Background on biotechnology .............................................................................. 2
2.2. Crop development ............................................................................................... 3
2.3. Welfare benefits ................................................................................................... 7
2.4. Policy and institutions ........................................................................................ 10
2.4.1. DA Biotech Program ...................................................................................................... 10
2.4.2. National Committee on Biosafety of the Philippines (NCBP) ....................................... 11
2.4.3. BPI Biotech .................................................................................................................... 11
2.5. Regulatory processes ........................................................................................ 12
2.5.1. Domestic regulatory processes ..................................................................................... 12
2.5.2. Amendments ................................................................................................................. 16
2.5.3. International interface .................................................................................................. 17
3. The case of Bt eggplant ...................................................................................... 18
3.1. Crop development ............................................................................................. 18
3.2. Methodology ...................................................................................................... 19
3.2.1. Conceptual framework ................................................................................................. 19
3.2.2. Data collection and analysis .......................................................................................... 21
3.3. Economic surplus analysis of Bt eggplant .......................................................... 21
3.4. Comparisons ..................................................................................................... 23
4. Synthesis of challenges ...................................................................................... 24
5. Recommendations and ways forward ............................................................... 24
5.1. Regulatory framework and process ................................................................... 24
5.2. Institutional concerns ......................................................................................... 24
5.3. Production and marketing .................................................................................. 25
5.4. Policy, legislation ............................................................................................... 26
6. References ........................................................................................................... 28

List of Figures
Figure 1. GM corn adoption data of regions per trait, 2003-2020 .......................................... 5
Figure 2. Cumulative GM corn adoption data by island group, 2003-2020 ............................ 6
Figure 3. Total GM corn adoption data by trait, 2003-2020.................................................... 6
Figure 4. Global farm income benefits from GM crops in USD million, 1996-2016 ................ 7
Figure 5. Number of research proposals submitted to NCBP and DOST-BC by various
institutions, 1991-September 2021 ...................................................................................... 10
Figure 6. Number of food, feed, and direct use approvals, 2003-2014 ................................ 10
Figure 7. Proposal procedure .............................................................................................. 13
Figure 8. Biosafety guidelines for confined tests ................................................................. 14
Figure 9. Biosafety guidelines for field trials ........................................................................ 14
Figure 10. Biosafety guidelines for direct use for food, feed, or processing (FFP) ............... 15
Figure 11. Biosafety guidelines for commercial propagation................................................ 15
Figure 12. Guidelines for deregulation ................................................................................ 16
Figure 13. Key comments on JDC 2016-01 Amendments ................................................... 16
Figure 14. Graph of closed economy model ........................................................................ 20

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List of Tables
Figure 1. GM corn adoption data of regions per trait, 2003-2020 .......................................... 5
Figure 2. Cumulative GM corn adoption data by island group, 2003-2020 ............................ 6
Figure 3. Total GM corn adoption data by trait, 2003-2020.................................................... 6
Figure 4. Global farm income benefits from GM crops in USD million, 1996-2016 ................ 7
Figure 5. Number of research proposals submitted to NCBP and DOST-BC by various
institutions, 1991-September 2021 ...................................................................................... 10
Figure 6. Number of food, feed, and direct use approvals, 2003-2014 ................................ 10
Figure 7. Proposal procedure .............................................................................................. 13
Figure 8. Biosafety guidelines for confined tests ................................................................. 14
Figure 9. Biosafety guidelines for field trials ........................................................................ 14
Figure 10. Biosafety guidelines for direct use for food, feed, or processing (FFP) ............... 15
Figure 11. Biosafety guidelines for commercial propagation................................................ 15
Figure 12. Guidelines for deregulation ................................................................................ 16
Figure 13. Key comments on JDC 2016-01 Amendments ................................................... 16
Figure 14. Graph of closed economy model ........................................................................ 20

iii
 Modern Biotechnology Application and Regulation
in the Philippines: Issues and Prospects

Sonny N. Domingo and Arvie Joy A. Manejar 1

1. Introduction

1.1. Background of the study

Biotechnology is defined as a modification and improvement of living organisms from living
genetic materials. Under this umbrella is modern biotechnology which employs genetic
engineering, gene technology, genetic modification, and gene manipulation among others to
produce genetically modified crops in the agricultural sector for instance (ISAAA nd).

While arguably contentious and open to cultural sensitivities, modern crop biotechnology
options have the potential to address sectoral problems on food security, agricultural
productivity, pest and disease infestation, and micronutrient deficiency. It is considered as a
multifaceted solution to the growing demand for food and resources as populations and
economies continue to grow. Increased yields and pest resistance, and improved farm incomes
are some of the more evident claims supporting the adoption of modern biotechnology crops.

The introduction of genetically modified (GM) crops in the Philippines started with the
regulatory approval for commercial propagation of Bt corn in the early 2000’s. Technology
adoption took off like wildfire, quickly achieving almost one million hectares of plantation in
various regions of the country.

The initial set of regulatory guidelines and policy through the Department of Agriculture (DA)
Administrative Order (AO) No. 08 series of 2002 were facilitative in directing the process of
assessment, approval and commercialization of GM crops. However, ensuing challenges and
resistance, mostly from anti-modern biotechnology groups necessitated a change in policy.
Executive Order 514 or the National Biosafety Framework of the Philippines was passed in
2006, enhancing regulations and risk assessment processes, including the clarification of
institutional roles and expanding the NCBP. EO 514 also considered compliance with the
provisions of the Cartagena Protocol and Codex Alimentarius.

The Supreme Court voided DA AO No. 08 in 2015 and was eventually replaced by Joint
Department Circular (JDC) No. 01 series of 2016. The Supreme Court also stopped the field
trials of Bt Eggplant and other GM crops in the pipeline, although the ruling was eventually
overturned a year later. The issuance of JDC No 01 instituted stricter biosecurity provisions
including the conduct of environmental impact assessments and public consultations.

Reviewing two decades of regulatory dynamism and policy application would help pinpoint
areas for improvement and possible augmentations toward the common goal of harnessing
benefits from modern biotechnology.

1
Senior Research Fellow and Research Specialist respectively, Philippine Institute for Development Studies

1
 1.2. Objectives
Generally, the study determined the issues and prospects in the application and regulation of
modern biotechnology in the Philippines’ agricultural sector.

Specifically, the study reviewed policy and related regulatory processes on modern
biotechnology; conduct case studies on technology development and commercialization; and,
looked at ways for modern biotechnology and agriculture to move forward.

1.3. Policy questions

Biotechnology has been introduced in the country as early as the 1970s, and the Philippines
was one of the first nations to adopt biotech crops. In comparison however to its earlier
counterparts, the local agricultural sector exhibited heavy dependence on maize crops but lags
in other commodities’ adoption rates and approval events. This situation prompted a discussion
on policy and regulatory weaknesses related to development and commercialization of modern
biotechnology in the country’s landscape.

The presence of modified improved crops in international markets also gave rise to welfare and
environmental policy debates. While modern biotechnology ensured benefits, risk mitigation
in other aspects remained much of a gray area. Trade regulations like Cartagena Protocol and
National Biosafety Framework were good avenues of regulations, but the extent of their
guidelines left much to be qualified. This circled back to the last policy question of what
necessary augmentations should be undertaken to facilitate ideal outcomes of modern
biotechnology-related regulatory processes.

2. National landscape

2.1. Background on biotechnology

Growing industrialization and structural transformation characterized most of developed
economies while developing countries’ agricultural income lagged vis-à-vis non-farm
economies in a situation called Schultz stage. These gaps led to disparities between rural and
urban locations and depleted the resource base which exacerbate lagged productivity and food
insecurity (Barrett et al. 2010). Agriculture expansion was the immediate option but may not
always be the case when resource inputs like land and water remained finite (Anthony &
Ferroni, 2012), thus the consideration for biotechnology.

Biotech crops were the fastest adopted technology in modern agriculture. Global trade figures
in 2010 showed 90 percent of the 15.4 million farmers planted insect or herbicide resistant
biotech crops. With their increased yield from developing countries, it was set to outpace the
production of industrialized nations (Anthony & Ferroni, 2012). The ease of adaptability across
small and large farms, and the upgrading of attributions (seed care and coating, resilience
against climate stresses, and pest resistance) also contributed to the uptake (Asia News Monitor
2014; Anthony & Ferroni 2012).

The introduction of biotechnology to world markets caused three economic responses: (a)
supply shifts in emerging economies, leading to global price decline; (b) import regulations;
and (c) emergence of niche markets for organic and conventional substitutes (Gruère et al.,
2011). It also enabled cross-country multilateral trades under the trade liberalization strategy
of the World Trade Organization (WTO). Their strategies to ease market barriers and
standardize regulations reportedly affected developing countries the most as they may not have

2
the capacity to comply with international standards, lack mechanisms to protect domestic
production, or find it costly to meet regulations (Dibden, Higgins, & Cocklin, 2011).

In the context of the Philippines, the agricultural sector contributed 10.2 percent share to its
gross domestic product 2 in 2020, but it reported the least contraction from the COVID-19
pandemic at only 0.2 percent negative change 3, highlighting its significance in ensuring food
security amidst disruptions. Harnessing biotechnology and its promise of increased
productivity yields can be instrumental in sustaining and improving agricultural outputs.

2.2. Crop development

Around 71 countries adopted biotech crops and were observed to reach saturation levels.
Adoption and commercialization between 1996 and 2019 have reached cumulative figures of
190.4 mhas (million hectares) and USD 2.7 billion revenue, respectively.

Corn, soybeans, cotton, and canola were the first four crops developed and adopted in
biotechnology, but the list eventually covered alfalfa, sugar, beets, papaya, squash, eggplant,
tomatoes, mustard, sweet potato, and cassava. Table 1 showed area and adoption rates of top
biotech crops while Table 2 listed the distribution by country.

Philippines was ranked 12th with 0.9 million hectares of corn among mega-biotech countries.
It placed second after India in the Southeast Asian region in terms of adoption area. Asia, in
total, comprised 32.2 percent of the global production of 184 million hectares of corn (ISAAA,
2019).

Table 1. Area and adoption of biotech crops, 2019

Commodity Area (in mhas) Adoption rate
Soybeans 91.9 48.2
Maize 60.9 32.0
Cotton 25.7 13.5
Canola 10.1 5.3
Other 1.8 1.0
Note: Other includes sugar beets, potatoes, apples, squash, papaya, and brinjal/eggplant
Source: ISAAA 2019

Table 2. Area and adopted crops by country, 2019

Rank Country Area (mhas) Biotech crops
1 USA 71.5 Maize, soybeans, cotton, alfalfa, canola, sugar beets,
potatoes, papaya, squash, apples
2 Brazil 52.8 Soybeans, maize, cotton, sugarcane
3 Argentina 24 Soybeans, maize, cotton, alfalfa
4 Canada 12.5 Canola, soybeans, maize, sugar beets, alfalfa, potatoes
5 India 11.9 Cotton
6 Paraguay 4.1 Soybeans, maize, cotton
7 China 3.2 Cotton, papaya
8 South 2.7 Maize, soybeans, cotton
Africa

2
Agriculture contributed 9.2 percent in 2019 GDP.
3
Industry contracted by 13.1 percent while services by 9.1 percent (PSA 2021).

3
 Rank Country Area (mhas) Biotech crops
9 Pakistan 2.5 Cotton
10 Bolivia 1.4 Soybeans
11 Uruguay 1.2 Soybeans, maize
12 Philippines 0.9 Maize
13 Australia 0.6 Cotton, canola, safflower
14 Myanmar 0.3 Cotton
15 Sudan 0.2 Cotton
16 Mexico 0.2 Cotton
17 Spain 0.1 Maize
18 Colombia 0.1 Maize, cotton
19 Vietnam 0.1 Maize
20 Honduras <0.1 Maize
21 Chile <0.1 Maize, canola
22 Malawi <0.1 Cotton
23 Portugal <0.1 Maize
24 Indonesia <0.1 Sugarcane
25 Bangladesh <0.1 Brinjal/Eggplant
26 Nigeria <0.1 Cotton
27 Eswatini <0.1 Cotton
28 Ethiopia <0.1 Cotton
29 Costa Rica <0.1 Cotton, pineapple
Total 190.4
Note: Figures are rounded off to the nearest hundred thousand. Those who grow more than 50,000 ha or
more are identified as the top 19 biotech mega-countries.
Source: ISAAA 2019

Bt corn was the first commercially available GM crop in the Philippines after eight years of
application process. Since it was developed outside, Bt corn only underwent field trials under
DAO 2008-02 with DA as the sole assessor for multi-location field trials, commercial
propagation, and importation for direct use. Table 3 showed the history of corn application and
approval events from its introduction in 2002 to 2014.

Table 3. Approval of biotech corn events in the Philippines, 2002-2014

Event Trait Year of Approval/Renewal
MON810 IR 2002/2007
MON863 X MON810 IR 2004
NK603 HT 2005/2010
Bt11 IR 2005/2010
MON810 X NK603 IR/HT 2005/2010
GA21 HT 2009
Bt11/GA21 IR/HT 2010
MON89034 IR/HT 2010
MON89034 X NK603 IR/HT 2011
TC1507 HT 2013
TC1507 X MON810 HT/IR 2014

4
 TC1507 X MON810 X NK603 HT/IR 2014
TC1507 X NK603 HT 2014
Source: ISAAA 2018
Figure 1 showed the adoption trend of GM corn varieties across the years. Insect resistant (IR)
corn was present from 2003 to 2012, reaching its peak in 2007 with 120,000 hectares. These
were comprised largely by Regions I, II, and III. Herbicide tolerant (HT) varieties entered in
2006 and reached its highest adoption in 2013 with over 160,000 hectares. It was likewise
dominated by Region II, followed by Regions XII and X. HT varieties eventually dwindled
after 2013.

Stacked traits, a combination of HT and IR, came in by 2007 and easily surpassed the adoption
area of the individual traits. Caraga farmers, apart from the usual Region II figures, adopted
the trait only in 2017 and pushed the area beyond one million hectares.

Figure 1. GM corn adoption data of regions per trait, 2003-2020

Notes: Stacked = HT and IR; 2014 covers January 2014 to March 2015; 2015 covers April 2015 to March 2016;
2016 covers April 2016 to March 2017; 2017 covers April 2017 to March 2018; 2018 W (Wet Season) covers
April to July 2018; 2018 D (Dry Season) covers August 2018 to February 2019. 2019 W covers March to July
2019; 2019 D covers August 2019 to February 2020; 2020 W covers March to July 2020
Source: BPI Biotech Office 2021

Luzon dominated all three traits due to Region II’s large adoption figures. Visayas’ adoption
areas were dwarfed in comparison to its counterparts (Figure 2). The generally high values of
stacked traits indicated stronger preference of farmers towards the superior benefits of stacked
since its introduction in 2006 (ISAAA, 2019). IR GM corn was phased out in 2012, and HT
traits in 2020 wet season (Figure 3).

5
Figure 2. Cumulative GM corn adoption data by island group, 2003-2020

Source: BPI Biotech Office

Figure 3. Total GM corn adoption data by trait, 2003-2020

Source: BPI Biotech Office

6
 2.3. Welfare benefits
Empirical evidence backed the benefits espoused by biotechnology. In a showcase of farm
income benefits since biotech introduction in 1996 to two decades later, GM crops have been
able to generate USD 186,102.1 million farm income. Herbicide tolerant soybean provided the
highest gain with USD 54,524.4 million, then IR cotton, IR maize, and HT maize. These were
also the top crops adopted across countries.

Figure 4. Global farm income benefits from GM crops in USD million, 1996-2016

HT soybean 54,524.4
IR cotton 53,986.9
IR maize 50,565.5
HT maize 13,108.1
HT canola 5,970.9
HT+IR soybean 5,211.5
HT cotton 1,916.9
Others 817.9

Note: Others include virus-resistant papaya and squash, and herbicide-tolerant sugar beet
Source: ISAAA 2016

The yield productivity and mitigated loss from extreme weather events increased income of
corn farmers by 200 USD million per year. Those who have adopted biotech corn saw an eight
percent income advantage, 42 percent return of investment, and 19 percent increment in income
improvement. For the Philippines, income derived from biotech corn was around USD 92
million in 2013 alone and PHP 10,132 per hectare for farmer level (ISAAA, 2019).

There was also seasonal variability in income; Php 7,482 per hectare during dry season and
Php 7,080 during wet season. Net profitability was greater by four to seven percent during wet
season and three to nine percent for dry season (ISAAA, 2019). Much of the potential benefits
of biotechnology rested on its ability to resist extreme climate changes. For a typhoon-stricken
country, the estimated benefits would greatly help increase the quality of life of farmers and
sustain food security thresholds. Table 4 consolidated the benefits of Bt corn adoption based
on the SIKAP/STRIVE, Inc. Study as provided by DA Biotech Office.

Table 4. Farm benefits of GM corn

Benefits (in PHP) Bt corn HT trait Stacked trait
Net income 85 million 438 million 6.422 billion
Value of labor saved 12 million 117 million 645 million
Profit over mixed 8-85% higher 38-87% higher
seeds
ROI over mixed seeds 12-156% 73-160%
ROI over ordinary 6-9% 9-30%
hybrid corn
Source: SIKAP/STRIVE Inc. Study through DA-Biotech

7
 In a separate study by Klumper & Qaim (2014), a 22 percent yield increase was associated with
68 percent profit gain and 38 percent reduction in pesticide expenditure. The mitigated losses
created additional gains for biodiversity contribution at USD 150 billion, a very different angle
on contrary claims. Biotech farms were also observed to have significantly higher populations
of beneficial insects (ISAAA, 2019).

Biotech crops reportedly will not wipe out indigenous Philippine plants but will harness their
natural health traits to develop biopesticides. There were also no established environmental and
human health issues that would coexistence of organic farming and agriculture biotechnology
thus these options remain free for choosing among farmers (Asia News Monitor 2015a).

Examining active ingredient usage was one way of capturing environmental gains. For
instance, the shift to IR cotton reduced active ingredient usage by 288 million kg, and HT maize
by 239.3 kg. These transitions from herbicide and insecticide use averaged an 18.4 percent
change from status quo of pesticide usage (Table 5).

Table 5. Measuring impacts of transitions from herbicides and insecticides to GM

technology, 1996-2016

% change in environmental
Change in volume of AI used Change in field EIQ impact % change in AI use on impact associated with
GM trait
(million kg) (million field EIQ/ha units) GM crop herbicide and insecticide
use on GM crops

HT soybean 13.0 - 8,526.0 0.4 - 13.4

HT+IR soybean - 7.4 - 678.0 - 6.1 - 6.3
HT maize - 239.3 - 7,859.0 - 8.1 - 12.5
HT canola - 27.3 - 931.0 - 18.2 - 29.7
HT cotton - 29.1 - 706.0 - 8.2 - 10.7
IR maize - 92.1 - 4,142.0 - 56.1 - 58.6
IR cotton - 288.0 - 12,762.0 - 29.9 - 32.3
HT sugar beet 1.0 - 43.0 9.9 - 19.4
Totals - 671.2 - 35,647.0 - 8.2 - 18.4
Note: AI = active ingredient, EIQ = environmental impact quotient (a universal indicator where various envi
impacts of individual pesticides are integrated into a single field value per hectare. EIQ is multiplied by amount
of pesticide ai used per hectare to produce a field EIQ value)
Source: ISAAA 2016

Adoption of technology to smallholder farms depended on a number of factors, the first of

which was investment and funding levels. In the current landscape, this was shouldered by
private technology developers who can meet the high capital costs needed for the initial
distribution and adoption. The second factor was the strength of regulatory frameworks, but
the high development, long approval period, and regulatory costs could later develop as barriers
to entry too (Anthony & Ferroni 2012). Market sensitivity, international trade risks, and fear
of export losses further added to low confidence in trading and investment (Gruère et al., 2011).

Instances of patent challenges have stonewalled distributors and market providers. Heller &
Eisenberg (1998) referred to this term as tragedy of the anti-commons, leading to non-
utilization of seeds and related products which could have been beneficial for the public.
Anthony & Ferroni (2012) believed this could be overcome when local universities and
8
 institutions would conduct their own research and development to reinforce country ownership
on the knowledge development.

There was robust response on that front with around 346 proposals submitted to National
Committee on Biosafety of the Philippines (NCBP) and DOST-Biosafety Committee for
eventual funding between 1991 and 2021, bulk of which were proposed by international
research institutions and public universities. Out of the total, 308 were approved, five were
rejected, and the remaining 33 were withdrawn or incomplete. However, the country was
deemed incapacitated to transition from development to commercialization per DA’s insights.
The problem was rooted in the limited technical human resource (traditional breeders and
modern biotechnology researchers), and low retention rate of country experts. Knowledge and
technical transfer from trainings also suffered continuity gaps due to lacking facilities and
technology transfer offices.

Table 6. Research proposals submitted to NCBP and DOST-BC, 1991-September 2021

Government International
Private Public
Industry research research Total
university university
institution institution
Contained facility tests
Involving GMOs 20 6 97 29 117 269
Involving PHES 20 9 5 0 34
Not within purview of
1 1
NCBP/DOST-BC
Total 40 6 106 35 117 304
Field Tests
Involving GMOs 8 1 9
Involving PHES 1 1
Total 8 2 10
Confined Tests
Involving GMOs 2 3 8 18 31
Beyond purview of DOST-BC 1 1 1

Total 2 0 3 9 19 32
Approved 37 5 97 36 133 308
Not approved 1 3 1 5
Withdrawn or incomplete 13 12 6 2 33

Grand total 50 6 109 45 136 346

Source: DOST-NCBP Secretariat 2021

9
Figure 5. Number of research proposals submitted to NCBP and DOST-BC by various
institutions, 1991-September 2021
30

25
Count of proposals

20

15

10

0
1991
1992
1993
1994
1995
1996
1997
1998
1999
2000
2001
2002
2003
2004
2005
2006
2007
2008
2009
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
Industry Public university Private university International org Government R&D Institutions

Note: 1991-2008 cover proposals submitted to NCBP; 2009-Sept 2021 cover proposals submitted to DOST-BC
Source: DOST-NCBP Secretariat 2021

United States granted the highest cumulative number of approvals with a total of 539 events.
Meanwhile, the Philippines had 75 approvals in 2014 and ended with 244 in 2019. Food
approvals took up 116 events, 114 for feed, and 14 for cultivation. The low figure for
cultivation implied the country’s hesitancy to grow biotech crops and mirrored the sector’s
environmental risk aversion.

Figure 6. Number of food, feed, and direct use approvals, 2003-2014

Corn 46
Soybean 9
Potato 8
Cotton 7
Alfalfa 2
Sugar beet 1
Rice 1
Argentine canola 1

Source: DA Biotech 2014

2.4. Policy and institutions

2.4.1. DA Biotech Program
USDA funded the DA-Biotech Program as a foreign-assisted project from 2000 to 2013; it was
established to develop regulatory policy for modern biotechnology and create a policy
environment for technologies and biotechnology applications. AFMA’s provision (RA 8435)
on appropriation continued the funding after the program completion. Since then, its

10
bureaucratic structure was divided into Biotech Research for Development 4 ; Institutional
Capacity Enhancement 5 ; Information and Education Campaign 6 ; Policy Research and
Advocacy 7. These components have respective technical advisory groups and committees of
experts from academe and government institutions.

A steering committee filled with Department of Science and Technology-Philippine Council

for Agriculture, Aquatic and Natural Resources Research and Development (DOST-
PCAARD), University of the Philippines (UP) System, Department of Trade and Industry
(DTI), Department of Environment and Natural Resources (DENR), Philippine Chamber of
Commerce and Industry (PCCI), Biotech Coalition of the Philippines (BCP), and industry and
farmer representatives and chaired by the DA Undersecretary of Policy and Planning served as
supplemental support to DA’s structure.

2.4.2. National Committee on Biosafety of the Philippines (NCBP)

On the other hand, the issuance of Executive Order No. 430 in 1990 established the NCBP, a
policy-making body operating in ex-officio 8 composed of representative from Department of
Health (DOH), DENR, DA, DTI, and DOST as the secretariat. The National Biosafety
Framework (NBF), formulated in 2006 through EO 514 under NCBP, provided the foundation
for the entire regulatory structure.

NCBP’s institutional arrangement apparently hampered bureaucratic changes (e.g.

streamlining deadlines), a common problem among institutionalized ad hoc committees where
responsibilities are added on without sufficient support. Further, the regulatory direction was
between the process or the product safety remained a gray matter.

2.4.3. BPI Biotech

Bureau of Plant Industry (BPI) – Biotechnology Office acted as an entry point to applications
and permit issuances and overall was a key player in the regulatory process. Average annual
application of genetically modified (GM) crops would usually reach eight to ten, including
original and for renewal, those developed domestically, and those from outside institutions, but
the count dampened since the onset of the pandemic.

The aforementioned institutions were mandated to carry out certain provisions of pertinent
policies. Over time, the scope and extent of their power and bureaucratic influence changed as
the landscape for biotechnology in the country evolved.

Table 7. Lists of related policies and events on the evolution of Philippine agriculture
biotechnology
Year Policy/Activity
1990 Executive Order No. 430
Establishment of NCBP
1991 NCBP Biosafety Guidelines
1996 Bt corn greenhouse trial

4
Previously named as Biotech Research and Development. Supports research activities of public institutions
and provides laboratory protocols on biotechnology tools.
5
Main thrust divided into trainings, partnerships, and facility upgrades for regulatory and research agencies.
6
Fosters partnership with public, private, and non-government organizations to communicate benefits and
science behind biotechnology to improve acceptability rates
7
Commissions policy studies to inform eventual decisions and investments.
8
No mandated fund allocation or permanent personnel resource, but a separate technical working group was
formed within the committee to serve as its core manpower.

11
 Year Policy/Activity
1998 Papaya biotechnology network
1999-2001 Field testing of Bt corn
2000 Philippines entered Cartagena Protocol
2002 DA AO 2002-08
Required risk assessments aligned with CPB
Bt corn approval
2005 Herbicide-tolerant corn approved
2006 Formulation of NBF
2009 Completion of Bt eggplant confined trial
2010 Completion of Bt cotton field test
2011 Completion of golden rice field test
2015 SC ruling against Bt eggplant
Nullification of DA 2002-08
2016 Issuance of JDC 2016-01
Reversal of SC ruling
Source: SEARCA Biotechnology Information Center

2.5. Regulatory processes

2.5.1. Domestic regulatory processes
The DA’s Administrative Order 2002-08 initially guided the country’s regulatory process and
required science-based risk assessments in compliance with Cartagena Protocol. As an
offshoot, four permits were identified for each biotech crop application: application to field
test, application to release for propagation, application for importation for direct use, and
petition for delisting. DA served as the sole assessor throughout the whole process.

On December 8, 2015, the Supreme Court passed the ruling on ISAAA versus Greenpeace,
halting the regulatory and approval process of Bt talong and nullifying the DAO, citing the lack
of environmental and health precautionary measures (ISAAA, 2018).

The AO was soon replaced by Joint Department Circular (JDC) 2016-01. DA was joined by
DOST, DENR, DOH, Department of Interior and Local Government (DILG), DA-Scientific
and Technical Review Panel 9, and Institutional Biosafety Committees 10. The court decision
was eventually reversed in July 26, 2016 and granted nine motions for reconsideration to
petitioners (ISAAA, 2016).

Under the direction of JDC, the process was broken down into the following permit
applications, (1) confined tests, (2) single and multi-location field trials, (3) direct use for food,
feed, and processing (FFP), and (4) commercial propagation. Safety assessments from the JDC
members were conducted for each phase. Each agency was governed by their respective
processes and assessment guidelines based on corresponding aspects (e.g. DENR for
environmental safety, DOH for human health consumption) to avoid duplication. However,
overlaps may still occur between DA and Food and Drug Administration (via a third party) for
the FFP phase.

9
Pool of non-DA scientists to evaluate risk assessments, analyze issues raised by public, and evaluate petitions
for deregulation.
10
Company or institution applying for and granted permits shall constitute an IBC prior to the test. Should
have three scientist-members and two community representatives.

12
Proposals were evaluated initially by the proponent’s Institutional Biosafety Committees and
submitted to NCBP. Genetic manipulation was allowed only for public welfare and natural
environment, and if there were no other existing or foreseeable alternative approaches to
deliver the same outcome. NCBP’s own assessment will take at most eight weeks upon receipt,
and they may revert it back to IBC for revisions. Copies will also be furnished to agencies.

Figure 7. Proposal procedure

NCBP will conduct TWG formed upon

IBC assessment
biosafety proposal receipt, List of submitted
Proposal and evaluation,
assessment up to recommendations projects furnished
submitted to IBC submitted to
8 weeks upon submitted to to agencies
NCBP
receipt NCBP

Source: Author’s illustration based on DOST-NCBP’s Philippine Biosafety Guidelines

If approved, the next step will be confined test, but it must meet any one of the following
classifications: (1) GM crops commercially available in the country where they are developed,
and there is adequate information available for domestic assessment; (2) GM crops developed
locally in approved laboratories and screenhouse but data is sufficient for risk assessment; (3)
GM crops whose size and growth habits require areas not afforded by standard screenhouses
e.g. papaya; (4) other crops and events that warrant limited release under confined conditions.

The application will be initially evaluated by IBC and endorsed to DOST-Biosafety Committee
for site inspection and expert assessments from STRP and/or external panel. Their
recommendations shall not be submitted later than 30 days from receipt of inspection findings
of DOST-BC.

Public consultation in this phase would be conducted through posting of project information
sheet (PIS). The guidelines emphasized posting of simpler and laymanized PIS versions in
English and vernacular language for easier understanding of the community. The duration will
take three weeks, and proof of posting should be submitted to DOST-BC within 10 days from
last day of posting. If deemed necessary, the public hearing will be carried out. Further, a
comment period will commence for 30 days, and the proponent should respond to all queries
not later than 15 days upon receipt.

In the case where no comment was received, the proposal for confined tests will be assessed
within 60 days, and will be evaluated based on the contents of proposal, IBC’s findings, site
suitability, STRP and external reports review, public comments, and other relevant documents.

During the two-year validity of the permit, reconsideration requests can still be filed and
approvals revoked under these reasons: non-compliance with biosafety guidelines, reliable data
reporting threats to human health and environment, and other grounds as deemed reasonable
by DOST-BC. DA, DENR (environment), and DOH (human health) shall monitor effects for
confined trial.

13
Figure 8. Biosafety guidelines for confined tests

Initial review by
Endorsement of Initial assessment
Application for IBC evaluation of DOST-BC:
proposal by IBC by DOST-BC
confined test proposal formation of site
to DOST-BC Secretariat
inspection team

New data or Formal review by

DOST-BC Approval of
information on Request for DOST-BC, review
Assessment and project
risks, may lead to reconsideration by external
decision information sheet
disapproval experts as needed

Source: Author’s illustration based on DOST-NCBP’s Philippine Biosafety Guidelines

Field trials will follow, and each site shall be evaluated separately. If the area would fall within
an ancestral domain or protected area, the proponent must secure an FPIC 11 and PAMB 12
endorsement prior the biosafety process. The IBC-endorsed application will now go through to
BPI instead of DOST-BC, and will be evaluated and assessed by STRP, DOH-BC, and DENR-
BC.

The public hearing was explicitly required to invite representatives from LGUs, local
communities, IPs, agriculture and fisheries council, and PAMB. After which, Sangguniang
Bayan or Panlalawigan will provide endorsement. BPI will consolidate reports of consultation
and endorsement and forward these to DA-Biosafety Committee for evaluation and
recommendation and to BPI director for the approval.

Permit issuance will be granted for each field trial site, valid for two years and subject to
extension. The aforementioned revocation grounds are also applied in this process.

Figure 9. Biosafety guidelines for field trials

Technical Within 5 days

BPI decision
reports upon receipt
on Risk Preparation of
Application for submitted by of reports, BPI
acceptance evaluation by consolidated
field trial STRP, DOH- will decide to
within 5 days STRP report
BC, and approve
of receipt
DENR-BC consultation

DA-BC
Approval BPI to forward Submission of
evaluation SP/SP
within 5 days documents to report on Public
and endorsement
of receipt; DA-BC within consultation comment
recommendat within 30 days
otherwise 10 days of and LGU period
ion to BPI from conduct
denied submission endorsement
Director

Source: Author’s illustration based on DOST-NCBP’s Philippine Biosafety Guidelines

11
free, prior, and informed consent
12
Protected Areas Management Board

14
Direct use for food, feed, or processing followed field trials. While this process also stuck to
the same general process, layers were added, particularly on the assessment stage – BPI-Plant
Product Safety Services Division (PPSSD) for food safety standards, Bureau of Animal
Industry (BAI) for feed safety, and external experts for socio-economic considerations. The
public comment period now involved PIS’ circulation in two newspapers within 60 days. The
permit, once awarded, will be valid for five years.

Figure 10. Biosafety guidelines for direct use for food, feed, or processing (FFP)
BPI decision Evaluation by
Grace period
on BPI to furnish STRP and Submission of
Application for of 60 days to
acceptance agencies with agencies for technical
direct use correct
within 5 days application 30 days from reports to BPI
comments
of receipt receipt

Approval Report on Consolidated

DA-BC review Within 5 days
within 5 days public summary by
and of report, BPI
of receipt; comment BPI within 5
recommend shall forward
otherwise submitted to days of
within 10 days docs to DA-BC
denied BPI receipt

Source: Author’s illustration based on DOST-NCBP’s Philippine Biosafety Guidelines

The final stage in the regulatory process would be commercial propagation which should first
fulfill the following conditions: (1) biosafety permit is secured; (2) field trial conducted does
not pose risks; (3) food, feed, and safety studies do not show risks; (4) pest-resistance article is
registered with Fertilizer and Pesticide Authority (FPA). The evaluators for risk assessment
expanded to include FPA, BPI-PPSSD, and BAI. Public comment period followed that of FFP
permit and its validity.

Should an LGU prohibit commercial propagation in their jurisdiction, labelling of seeds and
GM crop products should explicitly state that propagation is not intended in those areas. This
also meant that guidelines for planting should comply with regulations of other agencies,
particularly that of DENR for environmental health. The approval would be still subjected to
revocation grounds in light of reliable information and aforementioned reasons.

Figure 11. Biosafety guidelines for commercial propagation

Evaluation by
BPI decision Grace period
Application for BPI to furnish STRP and Submission of
on acceptance of 60 days to
commercial agencies with agencies for technical
within 5 days correct
propagation application 30 days from reports to BPI
of receipt comments
receipt

Approval Report on
DA-BC review Within 5 days Consolidated
within 5 days public
and of report, BPI summary by
of receipt; comment
recommend shall forward BPI within 5
otherwise submitted to
within 10 days docs to DA-BC days of receipt
denied BPI

Source: Author’s illustration based on DOST-NCBP’s Philippine Biosafety Guidelines

15
A technology developer can apply for deregulation when they want a biotech crop to be taken
off regulations. Like any other permit, the petition will undergo 30 days of assessment before
the DA-BC convenes. Only one event application so far has been filed with BPI since the
passage of JDC but was not acted due to absent grounding provisions in the IRR.

Figure 12. Guidelines for deregulation

Evaluation by
Consolidate
Publication of Public comment STRP and
Petition to BPI petition with
petition period, 60 days agencies for 30
comments
days from receipt

DA-BC review and Within 5 days of Consolidated

Approval within 5 Submission of
recommend report, BPI shall summary by BPI
days of receipt; technical reports
within 15 days of forward docs to within 5 days of
otherwise denied to BPI
endorsement DA-BC receipt

Source: Author’s illustration based on DOST-NCBP’s Philippine Biosafety Guidelines

2.5.2. Amendments
The joint circular was supposed to address the lapses of the earlier regulatory framework
however, issues continued to emerge, the most prominent of which were bottlenecks during
assessments and public consultations. In light of these comments, the JDC underwent
assessment in 2021, and several key changes were proposed.

Renewals on permit validities were removed and replaced by one-time approvals. Routine
review will still be conducted upon receipt of new and reliable information against the biotech
crop. All independent assessments were also merged into one Joint Assessment Group. A
stakeholder remarked that this was noncompliant with the framework, but the agencies
reasoned out that biosafety committees will have at least 10 working days to independently
review the application prior to convening.

Moreover, public comment periods were shortened and would only need an LGU resolution
for endorsement. The NCBP secretariat stated that the period actually increased to 15 working
days due to ARTA mandate, but given that consultation timeline would be arbitrary, an
exemption from the policy has been submitted and pending feedback.

Deregulation will also be phased out, but greater emphasis will be directed to revocation
grounds so permits can be invalidated at any time. These shifts aimed to address the major
points of delay in the process, but they may arguably loosen the stringency in regulation.

Figure 13. Key comments on JDC 2016-01 Amendments

COMMENT DOST-DA-DENR-DOH-DILG RESPONSE
BPI’s Joint Assessment Group which will Representatives from DA, DOST, DENR, and DOH.
come from different agencies Shall be determined by BCs in these agencies (same
composition for previous JDC)

Pending applications prior to effectivity of Transitory provision: shall be processed under JDC
revised JDC subject to which circular? 2016-01 within 85 days of application

16
COMMENT DOST-DA-DENR-DOH-DILG RESPONSE
Upon issuance of biosafety permit for No deregulation under proposed JDC. BPI will
direct use, technology is deregulated. monitor compliance to permit conditions, can be
subjected to revocation instead
Realistic estimated timelines Reckoning of days stopped whenever more info or
clarification is needed.

Addressing delays Creation of JAG will reduce time required for risk
assessment process to be carried out. New
mechanism for application processing delineates the
risk assessment from public participation process.
Several applications evaluated at the same Multiple applications = multiple JAGs. Each JAG shall
time be responsible for risk assessment of each
application
On renewal of permit No more renewal, one-time approval. Upon new
information containing risks to human health and
environment, review will be conducted
Several sacrifices for revised JDC: dissolved Public comment period increased from proposed 10
public consultation mechanisms; law not to 15 working days. NCBP Secretariat will request
covering matters to biosafety to health and from ARTA an omnibus exemption for processing of
environment; removed possibility of all applications.
independent assessment because of JAG;
significant reduction of opportunity and
spaces for stakeholder dialogue
Absence of liability and redress mechanism Section 36 of JDC has remedies of JDC, applied in
cases of violations

Nonconformity of JDC to National Biosafety Under draft JDC, all applications shall be transmitted
Framework to DOST, DA, DOH, DENR-BC within 3 working days
of application receipt. BCs shall designate two reps
to JAG for a meeting within 13 working days. BCs
should have at least 10 working days to
independently review the application.
Several sacrifices for revised JDC: dissolved Public comment period increased from proposed 10
public consultation mechanisms; law not to 15 working days. NCBP Secretariat will request
covering matters to biosafety to health and from ARTA an omnibus exemption for processing of
environment; removed possibility of all applications.
independent assessment because of JAG;
significant reduction of opportunity and
spaces for stakeholder dialogue
Absence of liability and redress mechanism Section 36 of JDC has remedies of JDC, applied in
cases of violations

Source: Authors’ compilation

2.5.3. International interface

Optimizing the potential of biotechnology would ultimately depend on a country’s mechanisms
and structures on biosafety, labeling, and transboundary movement. Countries were expected
to provide traceability systems on the sources of biotech products, and guidelines allowing for

17
the coexistence of traditional and organic. However, developing countries fell short of such
expectations (Rao 2017).

Cartagena Protocol on Biosafety, which the Philippines was signatory of, was a non-mandatory
agreement that provided model policies and regulations on modified organisms. The extent of
this agreement only covered global market, and national standards were up to country
governments. The protocol also did not cover non-biosafety indicators such as socio-economic
acceptability and ethical considerations (Godfrey, 2013).

DA posited that the inclusion of socioeconomic considerations should be placed at the initial
stage before the conduct of simultaneous assessments; if there were no benefits to gain from
its development, investment could be better funneled to another technology.

The global biotechnology sector was generally pushing for harmonization of regulations under
one unified standard, however this may not be feasible as each country have their own risk
factors and regulatory processes retrofitted to their nuances.

3. The case of Bt eggplant

3.1. Crop development

Eggplant comprised one third of crop vegetables in the Philippines and while its production
value was estimated highest among similar crops, fruit and shoot borer would target the crop
during early vegetative and fruiting stages, resulting to lower marketable yields over time.
Farmers resorted to heavy use of pesticides to mitigate losses. One emerging alternative in the
future would be to adopt Bt eggplant which has lower EIQ than ordinary varieties (Francisco,
Health and environmental impacts of Bt eggplant, 2014).

Bt eggplant with resistance against the fruit and shoot borer was developed by Maharashta
Hybrid Seed Company (MAHYCO) 13 and first planted in Bangladesh in 2014. The crop had
now been adopted by 91,270 smallholder farmers. The Philippines followed suit in its
introduction in 2004, and the application progressed up to multi-location field trials in
Pangasinan and Camarines Sur from 2010 to 2012. However, the Court of Appeals ruled
against its field trials due to lacking scientific basis and under the basis of Writ of Kalikasan.
Table 8 compiled the comments carried over from the case that were deemed unresolved by
stakeholders in the recent amendment discussion of JDC 2016.

After its reversal in 2016, the application has been granted Biosafety Permit No. 21-078FFP
for food, feed, and processing event and was reported to almost complete its commercial
propagation approval (ISAAA 2021).

13
https://www.isaaa.org/gmapprovaldatabase/event/default.asp?EventID=351

18
Table 8. Compiled comments during the SC Ruling on Bt talong
COMMENT DOST-DA-DENR-DOH-DILG RESPONSE
Applicant chooses IBC Members (no Community representatives should meet JDC
dissenting opinion) qualifications 14, thoroughly screened by DA-BC
NCBP not sufficient oversight for NCBP mandate provided for by EO 514
people’s participation
Posting in Public Information Sheet in Field trial expected not to bring irreparable damage to
two places near field testing site not human health and environment
enough to raise awareness. Info too
complex for public posting.
Scientific and Technical Review Panel Revised JDC does not include the participation of JDC.
does not have a community Assessments to be done by Joint Assessment Group
representative. Supposed to evaluate (JAG)
risks.
Non-documentation of public Proof of conduct is LGU resolution from Sanggunian
consultation
No appeal procedure Section 35 of revised JDC provides for filing of request
for decision reconsideration

3.2. Methodology
3.2.1. Conceptual framework
Economic surplus analysis model was used to conduct an ex-assessment of technology
adoption of bt eggplant as a case study under various market situations and assumptions within
a closed economy. This was adapted from the work of Alston, Norton, and Pardey (1995),
Francisco (2006), Bayer et al. (2008), and Francisco, Aragon-Chang, and Norton (2014).

Both supply and demand curves were assumed linear and other commodity prices constant in
a closed economy model with partial equilibrium. The formulas for parameters were expressed
as followed:

Equation 1. Parameters for economic surplus model

Consumer surplus ∆𝐶𝐶𝐶𝐶 = 𝑃𝑃𝑡𝑡 𝑄𝑄𝑡𝑡 𝑍𝑍(1 + 0.5𝑍𝑍𝜇𝜇 )

Producer surplus ∆𝑃𝑃𝑃𝑃 = 𝑃𝑃𝑡𝑡 𝑄𝑄𝑡𝑡 (𝐾𝐾 − 𝑍𝑍)(1 + 0.5𝑍𝑍𝜇𝜇 )

Total surplus ∆𝑇𝑇𝑇𝑇 = ∆𝐶𝐶𝐶𝐶 + ∆𝑃𝑃𝑃𝑃 = 𝑃𝑃𝑡𝑡 𝑄𝑄𝑡𝑡 𝐾𝐾(1 + 0.5𝑍𝑍𝜇𝜇 )

Price change 𝑍𝑍 = 𝐾𝐾 𝜀𝜀 = - (𝑃𝑃(𝑟𝑟+1) − 𝑃𝑃𝑡𝑡 )/𝑃𝑃𝑡𝑡

𝜀𝜀+𝜇𝜇

Source: Bayer et al. (2008)

14
On IBC membership: Representative must not be affiliated with applicant, may include elected LGU officials,
residents and CSOs represented in Local Poverty Reduction Action Team pursuant to DILG MC 2015-45. For
multi-location, representative shall be designated per site. If it will affect cover AD or protected areas,
representative should either be IPs or PAMB.

19
Where 𝑃𝑃𝑡𝑡 and 𝑄𝑄𝑡𝑡 are price and quantities at time t. K is vertical shift of supply curve, and Z is
change in price due to supply shift. Absolute value of price elasticity of demand is expressed
as 𝜇𝜇 while elasticity of supply is 𝜀𝜀.

Figure 14. Graph of closed economy model

Adoption rate was based on expert’s opinion while majority of the variables were lifted as
proxy in existing datasets. The assumed production area for the whole Philippines was the
eggplant production in 2020 while average yield was generated from PSA’s cost and return
simulations. All costs were referenced from Francisco (2006) and Bayer et al. (2008), but these
were updated to 2020 prices using World Bank’s GDP deflator. All assumptions were listed in
the table below, following the parameters needed for the model.

Table 9. List of assumptions for economic surplus model

VARIABLE DEFINITION VALUE SOURCE/BASIS
PHP/ton Price per ton in PHP 14,860.00 OpenStat 2020
PHP/kg Mean price received by 14.86 Cost and returns of
farmers eggplant production, PSA
2020
Yield (t/ha) Average yield 11.14 OpenStat 2020
Total Philippines area Assumed production area for 21,780 OpenStat 2020
the whole Philippines
Extension cost Assumed extension cost (e.g. 59,749,821.80 Francisco 2014
public consultations)
Research cost As released or invested 38,505,092.71 Bayer et al. 2008, adjusted
to 2020 prices
Regulatory cost As paid/invested 31,534,343.17 Bayer et al. 2008, adjusted
to 2020 prices
Success probability Probability that yield increase 0.65
will be achieved
Supply elasticity 0.50 Francisco 2006
Demand elasticity 0.80 Francisco 2006
Annual depreciation of Assumed 0 technology 0.00
technology depreciation for the first 15
years

20
 VARIABLE DEFINITION VALUE SOURCE/BASIS
Proportional change in (0.18) Computed from Francisco
input cost 2014 data
Base quantity Average yield x production 242,629.20 Computed from OpenStat
area 2020 data
Source: Authors’ compilation

3.2.2. Data collection and analysis

Primary data gathering was conducted through key informant interviews (KII) and focus group
discussions (FGD) involving national and local agencies and research institutions. Secondary
sources were generated through ISAAA, PSA, DA, BPI, and DOST.

3.3. Economic surplus analysis of Bt eggplant

Using above parameters, simulations were carried out for bt eggplant’s adoption. The first of
these was supply elasticity under five scenarios: 0.50 for base model, 0.40, 0.25. 0.75, and 1.00.
The closer the price elasticity is to zero (0), the more inelastic 15 the supply curve is.

The internal rate of return (IRR) was highest at price elasticity of 0.25 and lowest at the
elasticity of 1. The more it reached elasticity where quantity supplied changed at the same
proportion with price, the lesser the IRR. Considering the lead time for input procurement,
production, seasonality, and marketing, bt eggplant cannot be easily produced or distributed
thus the values returned.

Table 10. Sensitivity analysis for supply elasticity

e 0.50 (base) 0.40 0.25 0.75 1.00
∆CS 1,457,496,139 1,537,879,619 1,687,875,280 1,302,677,651 1,191,489,579
∆PS 2,331,993,823 3,075,759,239 5,401,200,898 1,389,522,827 953,191,663
∆TS 3,789,489,962 4,613,638,858 7,089,076,178 2,692,200,478 2,144,681,242
Res Cost 38,505,093 38,505,093 38,505,093 38,505,093 38,505,093
Reg Costs 31,534,343 31,534,343 31,534,343 31,534,343 31,534,343

Ext Costs 59,749,281.80 59,749,281.80 59,749,281.80 59,749,281.80 59,749,281.80

Total Costs 129,788,718 129,788,718 129,788,718 129,788,718 129,788,718
Net Benefit 3,659,701,245 4,483,850,140 6,959,287,460 2,562,411,760 2,014,892,525
NPV 5% 1,883,425,445 2,313,357,250 3,604,682,698 1,310,989,185 1,025,346,875
NPV 10% 997,753,085 1,229,954,157 1,927,367,127 688,578,300 534,295,653
IRR 53.1% 56.5% 64.0% 47.4% 43.6%
Source: Authors’ calculations

The second simulation was for different cost scenarios. This aimed to capture the increasing
costs that may be demanded at any particular stage of the adoption process. Containment would
usually take two years of testing, field trials (limited and multi-location) two years,

15
Changes in price will not change the quantity supplied. Relatively inelastic supply (1>n>0) means the
percentage change in quantity supplied changes by a lower percentage than the change in price. A unit elastic
supply with a price elasticity value of 1 means the change in price will be followed with a proportional change
in quantity supplied.

21
commercialization stage for one year, and extension through public consultations and farmer
dialogue which can occur throughout all nine years of the regulatory process.

Table 11. Cost scenario breakdown

Base 75% of base 125% of base Double Quadruple
regulatory
Time Time Time Time Time
procedure Cost (PHP) Cost (PHP) Cost (PHP) Cost (PHP) Cost (PHP)
(years) (years) (years) (years) (years)

containment 5,974,928.18 2 4,481,196 2 7,468,660 2 11,949,856 2 23,899,713 2

ltd field trial 6,638,809.09 1 4,979,107 1 8,298,511 1 13,277,618 1 26,555,236 1

multi-location ft 6,638,809.09 1 4,979,107 1 8,298,511 1 13,277,618 1 26,555,236 1

commercialization 6,306,868.63 1 4,730,151 1 7,883,586 1 12,613,737 1 25,227,475 1

Extension 6,638,809.09 9 4,979,107 9 8,298,511 9 13,277,618 9 26,555,236 9

Source: Adapted from Bayer et al. (2008)

The IRR from the base model was estimated at 53.1 percent. The simulation below intuitively
followed that the higher the costs, the lesser the rate of return. However, the decrease in IRR
was not as drastic; and the quadruple increase in costs still resulted to a 41.6 percent IRR,
relatively higher in comparison to the base value.
Table 12. Sensitivity analysis of under various cost scenarios
75% of base 125% of base Double Quadruple
∆CS 1,457,496,139 1,457,496,139 1,457,496,139 1,457,496,139
∆PS 2,331,993,823 2,331,993,823 2,331,993,823 2,331,993,823
∆TS 3,789,489,962 3,789,489,962 3,789,489,962 3,789,489,962
Res Cost 38,505,093 38,505,093 38,505,093 38,505,093
Reg Costs 23,650,757 39,417,929 63,068,686 126,137,373
Ext Costs 44,811,961.35 74,686,602.25 119,498,563.59 238,997,127.19
Total Costs 106,967,811 152,609,624 221,072,343 403,639,593
Net Benefit 3,682,522,151 3,636,880,338 3,568,417,620 3,385,850,370
NPV 5% 1,898,735,018 1,868,115,871 1,822,187,151 1,699,710,563
NPV 10% 1,008,346,806 987,159,363 955,378,199 870,628,427
IRR 54.3% 52.0% 48.8% 41.6%
Source: Authors’ calculations

The next simulation tackled the timeline of adoption. It hoped to capture the consequences of
delays (lags) and efficiencies (gains) in the regulatory process. The base model started the
adoption at Year 9, but uptake among farmers as early as Year 5 would result to a 112.3 percent
IRR while delays into Year 12 would decrease IRR to about 21.2 percent. Comparatively, the
postponement of adoption has far greater foregone losses than an increase in regulatory costs.

22
 Table 13. Sensitivity analysis of adoption timelines
Adoption at
Adoption (2) Lag 1 year Lag 2 year Lag 3 year Gain 1 year Gain 2 year Gain 3 year
Year 5
∆CS 2,712,217,489 1,143,250,764 804,662,742 488,403,915 247,114,306 1,504,265,133 1,887,383,709 2,291,010,516
∆PS 4,339,547,983 1,829,201,223 1,287,460,386 781,446,264 395,382,889 2,406,824,213 3,019,813,934 3,665,616,826
∆TS 7,051,765,472 2,972,451,987 2,092,123,128 1,269,850,178 642,497,194 3,911,089,346 4,907,197,644 5,956,627,342
Res Cost 38,505,093 38,505,093 38,505,093 38,505,093 38,505,093 38,505,093 38,505,093 38,505,093
Reg Costs 31,534,343 31,534,343 31,534,343 31,534,343 31,534,343 31,534,343 31,534,343 31,534,343
Ext Costs 59,749,281.80 59,749,281.80 59,749,281.80 59,749,281.80 59,749,281.80 59,749,281.80 59,749,281.80 59,749,281.80
Total Costs 129,788,718 129,788,718 129,788,718 129,788,718 129,788,718 129,788,718 129,788,718 129,788,718
Net Benefit 6,921,976,754 2,842,663,270 1,962,334,410 1,140,061,461 512,708,477 3,781,300,628 4,777,408,926 5,826,838,624
NPV 5% 4,007,740,485 1,461,292,150 976,261,643 544,608,105 225,041,201 2,004,098,693 2,608,619,081 3,276,694,074
NPV 10% 2,407,228,443 772,030,120 496,227,722 261,837,084 93,388,272 1,095,263,197 1,472,184,164 1,908,136,649
IRR 112.3% 49.5% 40.5% 31.4% 21.2% 59.6% 72.0% 88.5%
Source: Authors’ calculations

3.4. Comparisons
In terms of investment, DA funneled most of its assistance to Bt eggplant with a PHP 22.8
million counterpart, followed by GM corn, and Bt cotton.

Table 14. Investment comparison among GM crops

GM Crops Total investment Agency counterpart
Bt eggplant 21,993,661.66 22,836,885.90
GM corn 29,387,384.92 6,586,477.70
Bt cotton 16,276,358.29 4,279,172.00
GM abaca 551,954.09 -
GM cotton and GM abaca
2,700,000.00 -
(combination)
Transgenic papaya 13,390,800.78 -
Golden rice 15,400,000.00 3,690,468.00
Source: DA-Biotech Office 2021

The next table compared the regulatory process among various biotech crops in the country.
The delays were evident given the duration in years, three of which passed through two
regulations and undergoing a third without final approval for commercial propagation. While
regulatory security was fulfilled, this stringency also foregone additional productivity and
welfare for farmers.

Table 15. Regulatory process comparison among GM crops in the Philippines

Crop Application Confined Field trials Direct use for Commercial
proposal tests FFP propagation
PRSV Papaya 1998 2012 2014 (1st site)
BT Cotton 2009 2010-2011 2018
Golden rice 2017 2017-2018 2019 2019 2021
Bt eggplant 2005 2005-2007 2010-2012 2021

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4. Synthesis of challenges

Although the need for technological novelty in agriculture is palpable, barriers in the
development and uptake of modern biotechnology products remain evident. Low productivity,
pest and disease infestation, and compromised quality of produce can all be addressed through
modern biotechnology products, but lengthy and stringent regulatory processes and high
technology development costs have kept most of local agriculture from fully benefitting from
such advancement. Aside from GMO corn varieties, which passed vetting during the early
2000’s, the Philippine agriculture has yet to fully harness the potential this technological
novelty offers.

Concerns range from obstructive regulatory framework and processes, bureaucratic

inefficiencies and institutional limitations, high investment cost for R&D, market protection
and intellectual property issues, and resistance from interest groups. Action can be from
different fronts: regulations and processes need to be streamlined and harmonized, involved
institutions need to be capacitated with permanent dedicated structure and staff for biosafety
assessment, and community and stakeholder education and participation need to be enhanced.

Evidences abound with GMO corn already benefitting local growers for almost two decades
since hurdling early regulatory requirements. Ex ante projections on Bt eggplant development
and eventual commercial adoption also points to high returns from modern biotechnology. The
newly approved golden rice for commercial propagation further promises huge welfare returns.
Such validate positive claims on modern biotechnology from available literature, and provide
the impetus in prudently streamlining and possibly fast-tracking vetting processes.

5. Recommendations and ways forward

5.1. Regulatory framework and process

While policy amendments are necessary to ease regulatory lags, the current set of biosafety
framework and relevant guidelines is an attempt to balance product safety concerns and
agricultural sector needs. Albeit stringency is necessary, current regulatory inefficiencies
inevitably lead to massive opportunity costs due to associated delays and bottlenecks as seen
in the economic surplus runs, and actual encountered issues in processing Modern
Biotechnology product applications. There must be a way to shorten the laboratory-to-market
route and timeline without compromising environment and consumer safety.

Short to medium term interventions to minimize foregone welfare for both technology
developers and product consumers must focus on ensuring clarity in policy interpretation and
implementation; including institutional and stakeholder roles and participation. The Inclusion
of public review, consultation, and local stakeholder engagement are critical in addressing
technology transfer apprehensions, and in ensuring the appropriateness of developed modern
biotechnology products to local requirements. Medium to long term strategies must include
policy revision and institutional augmentation.

5.2. Institutional concerns

Implementation issues are sometimes rooted in institutional inefficiencies and procedural
bottlenecks. The agencies’ approach should be able to address these bureaucratic limitations
that hamper the process covering an essentially two-stage vetting process in the Philippines:
environmental safety approval and food-feed-processing approval. The ideal would be to come
close to a lean centralized process as espoused by other countries (i.e. Bangladesh), with

24
prudent institutional involvement from relevant government bodies, while being true to
biosafety principles and standards. Process redundancies must be minimized to rationalize
approval timelines.

Addressing organizational structure instability and non-retention of institutional memory due

to staff movement are key in promoting continuity and procedural integrity. Human capital
investment must also help reverse high personnel turnover, and the prevalent practice of non-
permanent designation of staff to biosafety regulatory functions. Personnel development
initiatives must also answer bureaucratic weaknesses, particularly on the lack of capacity
building and professional progression within the service, amid the rapid pace of biotechnology
advancement.

5.3. Production and marketing

Notwithstanding the positive claims by supporters and proponents of modern biotechnology,
certain interest groups and a part of the general public still need convincing regarding the safety
and acceptability of GMO crops and their products. An apt information and education (IEC)
campaign is key in bridging the knowledge and perception gap. Value chain stakeholders must
also be capacitated not only on the technical merits of modern biotechnology products, but also
on how to handle cultural sensitivities amid disinformation and valid scientific challenges.

Except for GMO corn growers who have been planting enhanced crop varieties for almost two
decades now, most Filipino farmers need proper appreciation and training on the novelty, and
cultural and handling requirements of modern biotechnology crops and their products. This
will be apparent once the commercial propagation and distribution of golden rice (and soon Bt
eggplant) takes traction in the country. Although the input requirements may not significantly
differ in the cultivation of GMO crops, their presence in the field together with traditional
varieties may be a cause for alarm. Organic crop and heirloom variety producers will
particularly not be welcoming when it comes to proximity concerns in the field.

Appropriate GMO product labeling is also necessary to address consumption hesitancy,

promote transparency under a sensitive and competitive environment. GM crops and traditional
and organic products must be able to coexist in both the field and market without displacing or
compromising the production integrity of one or the other.

Farmers and intermediaries will be especially interested on seed distribution, and input cost
and cultural management differences. Those in the academe and agricultural research must be
vigilant in looking at pest resistance to GM varieties.

ISAAA (2019) encouraged provision of material inputs, stronger technical assistance, enabling
policy environment on modern biotechnology adoption and uptake. Given the experience with
GM corn where there is the proliferation of expired seeds and black market, the DA is
recommended to put up regulatory and enforcement mechanisms and standards on seed quality,
price and distribution. Alternative markets should not be monopolized by financiers or traders
to further ease market barriers.

A complementary move is to provide incentives for local researchers delving further into
modern biotechnology. A short term move for now is to augment funding for process screening,
monitoring and evaluation, and research and development. Inadequate funding or
appropriations for institutions looking into the application of modern biotechnology, like the

25
Bureau of Plant Industry, compromises monitoring and evaluation activities and service
delivery 16, including conduct of biotechnology proposal and program/project assessment.

Intellectual property protection issues need to be addressed, as not doing so will disincentivize
technology development proponents and cause instability and possibly market failure within
the value chains. There is no policy provision lodged in current regulatory frameworks on
proprietary rights, but there is a Plant Variety Protection Office under the BPI that serves to
protect local plant breeders. Emerging threats and problems include IP infringements (i.e. use
of proprietary genetic materials from GM crops without the consent of technology developers)
and entry of substandard or lower quality seeds through informal channels or black market.

5.4. Policy, legislation

Recommendations in the longer term point to augmentations in the biosafety framework,
revision of EO 514, and passage of the Modern Biotechnology Act or a legislative form
thereof 17 . An applicable legislation should establish a central authority on modern
Biotechnology in the Philippines may it be under the current stewardship of DOST or another
institutional arrangement. The regulatory processes among involved national government
agencies need to be streamlined to minimize decision-making lags and attached regulatory
costs.

The amendment of the implementing rules and regulations of JDC 2016-01 is considered the
most feasible entry point in the short term. It is expected to include the following:

1. Harmonization of processes in one regulatory flow, common time frames, and

simultaneous evaluations;

2. Conduct of risk assessments for relevant agencies;

3. Clarification of areas of inconsistencies, delineation of roles and sequences among

involved institutional bodies;

4. Rationalization of public hearing and community engagements to a manageable

frequency and number;

5. Reduction of the length of joint assessment periods;

6. Removal of renewal for commercial propagation and field trials and creation of one-
time approval and lifetime permit 18

More comprehensive regulatory provisions may be required with the rapid advancement in
modern biotechnology and related fields, as well as the growing list of genetically modified
commodities and their products entering both global and domestic markets. Focus may be
given to stringent GM food labeling, low level presence detection and appraisal, GM animals
regulation, and new plant breeding techniques to complement modern biotechnology. The same
policy augmentations must serve to protect the consuming public and the integrity of the

16
Ongoing monitoring on weed resistance of ongoing field trials in preparation for future claims. This project is
not programmed with funds as it does not have legal basis.
17
House Bill No. 3372 filed by Representative Sharon Garin for the Eighteenth Congress.
18
For context, permit for field trial expires after two years; commercial propagation, and FFP after five years.
BPI Biotech Office requested to have continuous oversight monitoring function over approved commodities in
the new JDC.

26
environment, while not stifling the advancement of technology and its adoption by farmers and
local value chain stakeholders.

The huge opportunity losses attached to suboptimal bureaucratic regulatory functioning have
to be stemmed. Notwithstanding contrary sentiments, Fully vetted modern biotechnology crops
and products have their place in improving the productivity of the agriculture sector, with great
potential welfare benefits for both local producers and consumers. The government’s priority
must be to make available the modern biotechnology option, in both farm and household table,
in the most prudent but expedient way possible.

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6. References

Aldemita, R. R., Villena, M. M., & James, C. (2015). Biotech Corn in the Philippines: A
Country Profile. Los Banos, Laguna: ISAAA and SEARCA - Biotechnology
Information Center.

Anthony, V. M., & Ferroni, M. (2012). Agricultural biotechnology and smallholder farms in
developing countries. Current opinion in BIotechnology, 278-285.

Dibden, J., Higgins, V., & Cocklin, C. (2011). Harmonising the governance of farming risks:
Agricultural biosecurity and biotechnology in Australia. Australian Geographer, 105-
122.

Francisco, S. R. (2014). Socioeconomic impacts of Bt eggplant: Evidence from multi-location

field trials. In R. V. Gerpacio, & A. P. Aquino, Socioeconomic Impacts of Bt Eggplant:
Ex-ante Case Studies in the Philippines (pp. 205-232). Los Baños, Laguna: ISAAA.

Godfrey, R. N. (2013). Case studies of African agricultural biotechnology regulation:

Precautionary and harmonized policy-making in the wake of the Cartagena Protocol
and the AU Model Law. Loyola of Los Angeles International and Comparative Law
Review.

House Bill No. 3372. 2019. An act promoting safe and responsible use of modern
biotechnology establishing the Biotechnology Authority of the Philippines for this
purpose and appropriating funds therefor.
https://www.congress.gov.ph/legisdocs/basic_18/HB03372.pdf (accessed on October
14, 2021).

ISAAA. (2016, July 27). Crop Biotech Update. Retrieved from ISAAA:
https://www.isaaa.org/kc/cropbiotechupdate/article/default.asp?ID=14627

ISAAA. (2018). Global status of commercialized Biotech/GM Crops in 2018: Biotech crops
continue to help meet the challenges of increased population and climate change.
Ithaca, NY: ISAAA Brief No. 54.

ISAAA. (2019). Global Status of Commercialized Biotech/GM Crops in 2019: Biotech Crops
Drive Socio-Economic Development and Sustainable Environment in the New Frontier.
Ithaca, NY: ISAAA Brief No. 55.

ISAAA. (2021, July 23). Science Speaks. Retrieved from ISAAA:

https://www.isaaa.org/blog/entry/default.asp?BlogDate=7/23/2021

ISAAA. (nd). Agricultural Biotechnology (A Lot More than Just GM Crops). ISAAA.

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