Biosafety Regulation: Opening up the debate -Lessons from Kenya and Philippines Workshop in Kenya, 15 - 16 November 2010

1. Civil Society Perspectives on
Biosafety Regulations in the
Philippines
Lee M. Aruelo
Third World Network (TWN);
Network Opposed to Genetically Modified Organisms
(NO2GMOs); and
Go Organic Mindanao (GOM)

2. Statement of the Problem:
 There has been an influx of different varieties of GM
crops in the Philippines for propagation and for food,
feed and processing, not to mention those that are
already pending for approval. What is problematic is
that there is not much to speak of in terms of
regulatory mechanisms in the country that can
assess risks to health and environment for the farm
and large-scale planting of genetically engineered
crops at present.

3. Philippines
Population:
+/- 100 Million
Total Land Area:
30 million has
47% or about 13
million ha
devoted to
agriculture

4. Biodiversity
Quality
Map

5. GMO Status: Facts
 The first GMO to be approved for commercial
release in the Phil in December 2002 was the
pest resistant Bacillus thuringiensis (Bt) corn
and is now cultivated all over the country.
 The Phils. is the FIRST country in Asia to
commercialize a GM crop for food, feed or
processing.

6. GMO Status: Facts
 There are 58 GMO applications approved by
the Bureau of Plant Industry since December
2002.
 There are 53 GMO applications approved for
Food, Feed and for Processing.
 There are 5 GMO applications approved for
Commercial Propagation.

7. GMO Status: Facts
 There are • RR Corn – herbicide tolerant corn by
four types of Swiss Syngenta AG (Corn GA 21)
• Bt corn – resistant to Asian Corn Borer
corn varieties by U.S. Monsanto Co. (Corn Mon 810)
cleared for • RR corn – herbicide tolerant corn by
commercial U.S. Monsanto Co. (Corn NK 603)
propagation • Bt corn – variety by Swiss Syngenta AG
(Corn Bt 11)
• Stack-Trait (Bt-RR) Corn by U.S.
Monsanto Co. (Stacked Corn Mon 810 x
NK 603)

8. GMO Status: Facts
 The plant varieties  Soybean
approved for direct  Canola
use as food, feed  Potato
and for processing
are..
 Cotton
 Sugar-beet
 Alfalfa
 Corn

9. Local Research and Development
 Insect-resistance (Bt eggplant)
 Nutrient enriched (Golden rice)
 Disease-resistance (PRSV papaya)
 Delayed ripening (GM Papaya; GM Banana; GM
Mango)
 Virus-resistance
 (Virus Resistant Sweet Potato)
 (Multiple Virus Resistant Tomato)
 (Virus Resistant Abaca)

10. Philippine Regulatory System
for Biotech Products

11. Philippine Regulatory System for
Biotech Products
1. Philippine Constitution
2. National Policy Statement on Modern
Biotechnology
3. Department of Agriculture (DA) Administrative
Order No. 8, s2002
4. Executive Order No. 514, The National Biosafety
Framework

12. Constitutional Polices
 Right to Health (Art. II, Sec. 15);
 Right to a Healthy Environment (Art. II, Sec. 16);
 Priority to Science (Art. II, Sec. 17);
 Role of the Private Sector (Art. II, Sec. 20);
 Rural Development (Art. II, Sec 21; Art. XIII, Sec. 5);
 Right to Information (Art. II, Sec. 28);
 Local Autonomy (Art. X, Sec. 2);
 Right to Participation (Art. XIII, Sec. 16) ;
 Science and Technology (Art. XIV, Sec. 10 and 12);
 Consumer Protection (Art. XVI, Sec. 9)

13. Pres. Gloria Macapagal-Arroyo
Administration’s Policy on Biotechnology
“We shall promote the safe and responsible
use of modern biotechnology and its
products as one of several means to
achieve and sustain food security,
equitable access to health services,
sustainable and safe environment, and
industry development”

14. Philippine Regulatory System for Biotech
Products
Department of Agriculture Administrative
Order No. 8, Series of 2002
Importation and Release into the Environment
of Plants and Plant Products Derived from
the Use of Modern biotechnology

15. Department of Agriculture Administrative
Order No. 8, Series of 2002
 Sets into place a process by which the DA will
conduct a formal determination of the safety of
plant and plant products derived from the use of
modern biotechnology.
 Under DA-AO 8, all biotech plant and plant
products for release into the environment for field
testing and propagation, or for importation for
direct use for food, feed, or for processing shall
undergo required safety tests.

16. Philippine Regulatory System for
Biotech Products
Executive Order 514 of 2006 or the
National Biosafety Framework (“NBF”)
The Office of the President issued on 17 March
2006 Executive Order No. 514 “Establishing the
National Biosafety Framework, Prescribing
Guidelines for Its Implementation, Strengthening
the National Committee on Biosafety of the
Philippines, and for Other Purposes”

17. Executive Order 514 of 2006 or the
National Biosafety Framework (“NBF”)
 The lead body to coordinate and harmonize inter-
agency and multi-sector efforts to develop biosafety
policies in the country is the National Committee on
Biosafety of the Philippines.
 The NBF applies to the development, adoption, and
implementation of all biosafety policies, measures, and
guidelines and in making biosafety decisions
concerning the research, development, handling and
use, transboundary movement, release into the
environment, and management of regulated articles.

18. Problems/Issues with the Current
GMO Regulations

19. Problems/Issues with the Current
GMO Regulations
 Lack of Labeling Mechanisms
 Insufficient Venue for Public Consultation
 Lack of Liability and Redress
 Substantial Equivalence
 Lack of Environmental Impact Assessments
 Safety Testing vs. Risk Assessment

20. Lack of Labeling Mechanisms
 the current labeling regulation of BFAD only
mandates a generic labeling of all
ingredients, having no reference to the
process by which the product is produced.
 at present, there is no GM labeling
regulation in the Philippines

21. Insufficient Venue for Public
Consultation
 The different provisions on “public
consultation” under DAO No. 8 require
only publication of the Public Information
Sheet which must contain the invitation
to send written comments.

22. Insufficient Venue for Public
Consultation
 Public consultation is fulfilled through the
posting of a Public Information Sheet
instead of full-blown actual consultations
with hearings and the opportunity to present
resource persons and other supporting
evidence

23. Lack of Liability and Redress
Regime
 Current regulations do not make anybody
including the TNCs that sell genetically
modified seeds responsible and
accountable for any damage to human
health and environment that may occur

24. Substantial Equivalence
Establishment of substantial equivalence is not a
safety assessment per se but that establishing
the characteristics and composition of novel
food as equivalent to those of a familiar,
conventional food with a history of safe
consumption means that the new product will be
no less safe under similar consumption patterns
and processing practices.

25. Substantial Equivalence
A GM food that is substantially
equivalent to an existing food should
not be subject to additional
regulatory requirements

26. Lack of Environmental Impact
Assessments
 DENR
 Refuses to apply EIA regulations on
GMOs
 Refuses to adopt regulations for
environmental assessment of GMOs

27. Safety Testing vs. Risk Assessment

28. Suggested Policy Development
Tracks

29. Fill Gaps in Existing Regulations:
BIOSAFETY LAW
 New concern due to wider application of
modern biotechnology in agriculture & other
areas (i.e., GM Virus; GE Tree; GE Fish; GM
Mosquito, etc.);
 Development at the International Level on
Biosafety – approval of the Supplementary
Protocol on Liability and Redress; Approval of
the Road Map for Risk Assessment in COP-
MOP5

30. Advocacy Vehicle:
NO2GMOs!

31. Network Opposed to Genetically
Modified Organisms or NO2GMOs!
 Anniversary Date: 4 December 1998
 Nature: loose network and intends to continue
maintaining such
 Leadership: Coordinator of the network is only be
for 3 years (i.e., TWN: 2008-2010); "Troika
Leadership" - where the current Coordinator
(TWN) works with the past Coordinator (SIBAT)
and future Coordinator (PAKISAMA): to ensure
continuity of the network

32. Network Opposed to Genetically
Modified Organisms or NO2GMOs!
 Programs and Activities
 Regular monthly meeting of the network, once a month, i.e.,
every last Thursday of the month; special or emergency
meeting as needed; rotating venue and sponsorship of the
meeting (food and documentation)
 Annual Year-End Evaluation and Planning
 Capacity building program (e.g., Staff Development)
 Education Information Campaign (e.g. Fora and symposia)
 Advocacy and lobbying activities (national & local) either as a
network (GM Labelling Bill) or bilateral collaboration of
members (GMO Ban Ordinance; Organic Agriculture
ordinance)
 massive information dissemination

33. Network Opposed to Genetically
Modified Organisms or NO2GMOs!
 Financial Resources: Network’s activities are
jointly funded by the member organizations;
“seed-fund”
 Communication: website; e-group; sms
 Major Campaigns:
 Bt Corn (Mon 810): 2002
 Bt Eggplant: on-going
 Golden Rice: to start…
 Advocacy Strategy: Organic Agriculture followed
by GMO Ban

34. Network Opposed to Genetically
Modified Organisms or NO2GMOs!
 Member Organizations: Action Group on Erosion, Technology and
Action (ETC), Consumer Rights for Safe Food (CRSF), Earth
Savers Movement (ESM), Environmental Broadcast Circle (EBC),
Ecological Society of the Philippines (ESP), Foundation for
Philippine Environment (FPE), Go Organic Alliance!, GRAIN,
Greenpeace-Southeast Asia,, JPICC-AMRSP, Lingkod-Tao-
Kalikasan (LTK), Magsasaka at Siyentipiko para sa Pag-unlad ng
Agrikultura (MASIPAG), Miriam Public Education and Awareness
Campaign for the Environment (Miriam-P.E.A.C.E), Mother Earth
foundation (MEF), Pambansang Kilusan ng mga Samahang
Magsaaka (PAKISAMA), Partido Kalikasan Institute (PKI), The
Philippine Development Assistance Programme, Inc. (PDAP),
Philippine Network of Food Security Programmes, Inc. (PNFSP),
Sarilaya, Southeast Asia Regional Institute for Community Education
(SEARICE), Sibol ng Agham at Teknolohiya (SIBAT), and Third
World Network (TWN)

35. Thank you!