Why the Philippine Supreme Court Ruled Against Bt Eggplant

THIRD WORLD NETWORK BIOSAFETY INFORMATION SERVICE 

Dear Friends and Colleagues 

Why the Philippine Supreme Court Ruled Against Bt Eggplant 

Bt eggplant (called Bt talong in the Philippines) is the world’s first genetically modified (GM) eggplant with insecticidal protein from the soil bacterium Bacillus thuringiensis (Bt). It targets the shoot and fruit borer insect pest.  

In 2010, the Institute of Plant Breeding at the University of Philippines at Los Banos (IBP-UPLB) obtained approval for field testing of Bt eggplant in seven sites in the country. This was contested by NGOs and individuals who filed a petition to the Supreme Court (SC) for a Writ of Kalikasan (or Nature) to protect and advance the right of the Filipino people to a balanced and healthful ecology. The TWN paper below explains the bases for the SC’s decision. 

The SC issued the Writ and permanently stopped the field testing of Bt talong on the basis of the non-implementation of the National Biosafety Framework, particularly in terms of shortfalls in the risk assessment and public consultation requirements. It also declared null and void the Department of Agriculture’s Administrative Order No. 8 governing the importation and release into the environment of plants and plant products derived from the use of modern biotechnology. The SC further found compelling reasons for the application of the Precautionary Principle, mainly that the release of GMOs into the environment threatened to damage ecosystems and public health. The effect of the ruling was also that until a new law or regulation was passed consistent with the Constitution, treaty obligations, and international laws, no GM ingredients, processes or products could be imported, field tested, or commercially propagated in the Philippines.  

On March 7, 2016, a new Joint Department Circular No. 1, Series of 2016 on Rules and Regulations for the Research and Development, Handling and Use, Transboundary Movement, Release into the Environment, and Management of Genetically-Modified Plant and Plant Products Derived from the Use of Modern Biotechnology was passed. This new circular will allow the issuance of fresh permits for the planting in or importing of genetically modified crops into the Philippines.

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Third World Network
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THE PHILIPPINE SUPREME COURT DECISION ON BT EGGPLANT

by Lee Aruelo[i] 

Introduction 

Bt eggplant (talong in Filipino language) is the world’s first genetically modified (GM) eggplant with insecticidal protein from the soil bacterium Bacillus thuringiensis (Bt). Bt eggplant targets the shoot and fruit borer insect pest of the crop. 

The original genetic engineering of the Bt Cry 1Ac gene into eggplant cells to produce Bt eggplant was done in India by Maharashtra Hybrid Seed Company (MAHYCO), the Indian subsidiary of US seed corporation, Monsanto. MAHYCO subsequently sub-licensed the technology as part of a USAID-supported project to University of the Philippines at Los Banos (UPLB). In 2004, through a research program, native varieties of eggplant from the Philippines such as Mara, Mistisa, Dumaguete Long Purple, and Casino were taken to India by Philippine scientists. The Bt gene was transferred to the Philippine varieties by conventional breeding (hybridization and selection). Seeds of F1 hybrids and Backcross 1 were then brought back to the Philippines in 2005-2006. Bt talong in the Philippines was developed by the Institute of Plant Breeding at UPLB (IBP-UPLB). The Bt eggplant variety development in the Philippines consists basically of backcrossing[ii]. IBP-UPLB obtained approval in March and June 2010 for multi-location field testing in the following areas: Pangasinan; Laguna; Camarines Sur; Leyte; Iloilo; Davao City; and North Cotabato. 

Writ of Kalikasan (or Writ of Nature) 

On April 26, 2012, non-governmental organisations, Greenpeace and MASIPAG, along with other pro-environment personalities in the Philippines, filed a petition to the Supreme Court for a Writ of Kalikasan[iii] (or Nature) and a Writ of Continuing Mandamus for the issuance of a temporary environmental protection order. The primary causes of action were the constitutional right to a balanced and healthful environment; and that the Bt talong field testing did not comply with the required public consultation under Sections 26 & 27 of the Local Government Code. 

The respondents were the Department of Environment and Natural Resources (DENR), Environment Management Bureau (EMB), the Department of Agriculture (DA), University of the Philippines Los Baños (UPLB) Foundation, UP Mindanao Foundation, and International Service for the Acquisition of Agri-biotech Applications (ISAAA). 

The Supreme Court issued the Writ of Kalikasan against the respondents and referred the case to the Court of Appeals (CA) for hearing, reception of evidence and rendition of judgment. The CA then proceeded to hear the merits of the case, adopting a method wherein the expert witnesses of both parties testify at the same time. 

The CA rendered its decision on May 17, 2013, in favour of the petitioners[iv]. However, two respondents—the Department of Agriculture and Institute of Plant Breeding, UPLB—filed an appeal against the CA’s decision.  On September 20, 2013, the CA reaffirmed its decision of permanent cease-and-desist against Bt talong field trials; and to protect, preserve, rehabilitate and restore the environment in accordance with the foregoing judgement of the Court[v]. The cease and desist order was based on the following grounds: 

• The Precautionary Principle[vi]. The CA concluded that the Precautionary Principle set forth in Section 1, Rule 20 of the Rules of Procedure for Environment Cases of the Philippines[vii] was relevant in the present controversy. Stressing the fact that the “overall safety guarantee of Bt talong remains unknown, the appellate court cited the testimony of Dr. Flerida Cariño (expert witness for the respondents) who admitted that the product was not yet safe for consumption because a safety assessment had still to be done. The Decision also quoted Dr. Ben Malayang (expert witness for the petitioners) who testified that the question of Bt talong’s safety demands maximum precaution and utmost prudence, bearing in mind the country’s rich biodiversity. Amid the uncertainties surrounding the Bt talong, the CA thus upheld the primacy of the people’s constitutional right to a balanced and healthful ecology.
• Irreversibility of GMOs released into the environment. The appellate court noted the possible irreversible effects of the field trials and the introduction of Bt talong to the market.
• Policy and regulation. Protocols on the realm of science should be brought into the realm of public policy (without the need for congressional enactment). The CA found that existing regulations issued by the DA and the Department of Science and Technology (DOST) were insufficient to guarantee the safety of the environment and health of the people. It concurred with Dr. Ben Malayang’s view that the government must exercise precaution “under the realm of public policy”, beyond scientific debate.
• Field testing. The testing or introduction of Bt talong into the Philippines, by its nature and intent, is a grave and present danger to (and an assault on) Filipinos’ constitutional right to a balanced ecology because it is an ecologically imbalancing event or phenomenon. The sole purpose of field testing is to test the efficacy and agronomic characteristics of the Bt talong’s resistance to the fruit and shoot borer only; it is not a safety test on health and environmental impacts. 

In addition, the appellate court pointed out that the Writ of Kalikasan issued by the Supreme Court stops the field trials of Bt talong as a procedure, but does not stop Bt talong research. Thus, there is no violation of UPLB’s constitutional right to academic freedom. 

The respondents; the EMB of DENR, the Bureau of Plant Industry (BPI) and the Fertilizer and Pesticide Authority (FPA) of the DA, the UPLB Foundation, the University of the Philippines (UP), and the ISAAA, filed a Petition for Certiorari to the Supreme Court seeking the reversal of the Court of Appeals’ Decision of May 17, 2013, and Resolution of September 20, 2013, which permanently enjoined[viii] the conduct of field trials of Bt talong. 

Decision of the Philippine Supreme Court  

The Philippine Supreme Court (SC) in its En Banc Decision[ix] on December 8, 2015, permanently stopped the field testing of Bt talong. Furthermore, the SC also declared null and void the DA’s Administrative Order No. 8, Series of 2002 (DAO 08-2002), which sets out the rules and regulations for the importation and release into the environment of plants and plant products derived from the use of modern biotechnology. Consequently, any application for contained use, field testing, propagation and commercialization, and importation of genetically modified organisms (GMOs) is temporarily stopped until a new administrative order is promulgated in accordance with the law. 

The above decisions of the SC were due to the non-implementation of the National Biosafety Framework (NBF) in the crucial stages of risk assessment and public consultation, including the lack of an Environmental Impact Statement/Assessment on the GMO field testing and the application of the Precautionary Principle.  

Lack of Risk Assessment  

Field trials for GM plants and crops in the Philippines are governed primarily by DAO 08-2002 and implemented by the DA through the Bureau of Plant Industry (BPI). Within the DA-BPI, it is the Scientific and Technical Review Panel (STRP) which, as an advisory body, is tasked to “evaluate the potential risks of the proposed activity to human health and the environment based on available scientific and technical information”. Under DA Special Orders 241 and 384 (2002), the STRP membership was expanded to include “an independent pool of experts tapped by the BPI to evaluate the potential risks of the proposed release of GMOs for field testing, propagation, food, and feed to human health and the environment based on available scientific and technical information”.[x]  

Under DAO 08-2002, a mandatory risk assessment of GM plants and plant products is required prior to their importation or release into the environment. A risk assessment must be science-based, carried out on a case-to-case basis, target a specific crop and its transformation event, adopt the concept of ‘substantial equivalence’ in identifying risks, allow review, and provide that the absence of scientific information or consensus should not be interpreted to indicate the absence or presence and level of risks.[xi]  

“Substantial equivalence embodies the concept that if a new food or food component is found to be substantially equivalent to an existing food or food component, it can be treated in the same manner with respect to safety (i.e., the food or food component can be concluded to be as safe as the conventional food or food component).”[xii] The safety assessment of a GM food is directed by the results of a comparison between it and its conventional counterpart. [xiii] 

According to Greenpeace, there is actually only one committee, i.e., the STRP, of three to five members which conducts the risk assessment, aided by an informal group, the DA’s Biotech Advisory Team (BAT) of representatives from government biotech regulatory agencies, namely, the BPI, BAI (Bureau of Animal Industry), FPA, DENR, Department of Health (DOH) and DOST. There is no independent pool of experts as provided for under DA Special Orders 241 and 384 (2002). Greenpeace also assails the government regulatory agencies for their refusal to open to scrutiny the names and qualifications of those in-charge of regulation and risk assessment, and for allowing the entry and use of all GMO applications requested by multinational companies so far.[xiv]  

The Supreme Court cited a lack of risk assessment as one of the causes for the declaration of nullity of DAO 08-2002. This was because the so-called risk assessment of the STRP was not robust enough. It had used substantial equivalence as the main principle of its assessment, rather than the precautionary principle. In addition, the STRP had evaluated the potential risks of the proposed release of the GMO for field testing based only on the available scientific and technical information submitted by the proponents of the GMO to be released. 

Lack of Public Consultation 

Associate Justice Marvic Leonen issued a concurring opinion in a separate document at the same time that the decision of the Supreme Court was released to the public.[xv] He detailed the defects of the public participation requirement outlined in DAO 08-2002, as follows: 

• The applicant for field testing of a regulated article is required to create an Institutional Biosafety Committee (IBC). It is the applicant who chooses the members of the IBC. The composition of IBC must include three scientist members and two community representatives who “shall not be affiliated apart from being members of the IBC and shall be in a position to represent the interests of the communities where the field testing is to be conducted". The manner of choosing the composition of the IBC is problematic. The applicant does not have any incentive to choose critical community representatives. The tendency would be to choose those whose dissenting voices are tolerable.
• For field testing under DAO 08-2002, the only opportunity for public participation is under Section 8, under which public consultation on an application is prompted by the posting of the Public Information Sheet on field testing in three conspicuous places in the barangay/city/municipality for three consecutive weeks. Interested parties are given thirty (30) days within which to file a written comment on the application. The posting of the Public Information Sheet in three conspicuous places near the field testing site is not enough to raise awareness regarding the field testing being applied for. The subject matter in transgenic transformation is too complex and its consequences too pervasive to simply raise awareness through the fictional notice of public posting.
• Under the NBF, there must be a posting on the internet to capture the attention of relevant stakeholders; this is not required under DAO 08-2002.
• The mechanism under DAO 8-2002 does not even require that local government authorities be appraised of the proposed field testing. Certainly, engaging local government authorities would invite more meaningful public discourse.
• The STRP is a group of three independent scientists that reviews the risk assessment conducted by the IBC. The STRP does not have a community representative. It is tasked to evaluate, based on the individual scientists’ own standards, whether the proposed field testing poses significant risks to human health and the environment. How the points raised during the mandatory public hearings will be considered in the issuance of the field testing permits is not covered by DAO 08-2002. In this regard, there is no (set) standard or (due) process (for the risk assessment).
• The nonchalance in the regulatory framework was best seen when the petitioners[xvi] alleged that there was some public consultation prior to field testing. These consultations, however, were not documented. The only proof of such consultations was a bare allegation made by one witness of the DA in her judicial affidavit.
• The absence of an effective mechanism for public feedback during the application process for field testing means the DAO 08-2002 failed to meet the public participation requirement of the Cartagena Protocol and the National Biosafety Framework. The current mechanisms have all the badges of a “greenwash”[xvii]; merely an exhibition of symbolic compliance to environmental and biosafety policy.
• The indifferent/casual approach to public participation during the application process is obvious as there is no appeal procedure for third parties under DAO 08-2002. The regulation does not consider that communities affected may want to question the exercise of discretion by the DA or the BPI. DAO 08-2002 only covers appeals by any person whose permit has been revoked, who has been denied a permit, or whose petition for delisting has been denied by the Director of the BPI. Procedural due process is thus taken away from the public. 

It must be stressed that DAO 08-2002 and related DA orders are not the only legal bases for regulating field trials of GM plants and plant products. Executive Order 514 (EO 514), establishing the National Biosafety Framework (NBF), clearly provides that the NBF shall “apply 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”. The NBF also mandates that decisions shall be arrived at in a transparent and participatory manner, recognizing that biosafety issues are best handled with the participation of all relevant stakeholders and organizations who shall have appropriate access to information and the opportunity to participate responsibly and in an accountable manner in biosafety decision-making processes.[xviii] 

EO 514 was enacted to comply with the administrative requirements of the Cartagena Protocol on Biosafety which include Article 23 of the Protocol. Article 23 stresses that the public must be consulted in the decision-making process regarding living modified organisms, and that the decision made in this regard must be communicated to the public.[xix] 

The NBF has a provision on public participation. While DAO 08-2002 only requires posting and publication of notices and information sheets, the NBF mandates a more transparent, meaningful and participatory public consultation with some residents and government officials and encourages submission of written comments. Considering the above minimum requirements under the most comprehensive national biosafety regulation to date in the Philippines, compliance with only DAO 08-2002 is not sufficient.[xx] 

Lack of Environmental Impact System Statement/Assessment on GMO field testing 

The NBF clearly mandates that concerned departments and agencies shall make a determination on whether the Environmental Impact System (EIS) should apply to the release of GMOs into the environment and issue joint guidelines on the matter.[xxi] Unfortunately, the petitioners, most particularly EMB-DENR, BPI and FPA, repeatedly argued that the subject field trials were not covered by EIS law.  

The SC pointed out that even without the issuance of EO 514, the EMB should have at least considered GMO field testing for an environmental impact assessment under existing regulations on new and emerging technologies, namely, Section 7(g) in the Revised Procedural Manual for DAO 2003-30 on the Overview of the Philippine Environment Impact Statement System (PEISS).[xxii]  

The EMB considers an Environmentally Critical Project (ECP) as one that is “likely to have significant adverse impact that may be sensitive, irreversible and diverse” and which “includes activities that have significant environmental consequences”.  In this context, and given the overwhelming scientific attention worldwide on the potential hazards of GMOs to human health and the environment, their release into the environment through field testing would definitely fall under the category of ECP.[xxiii] 

Atty. Segui, the Chief of the Legal Division of the EMB, during the hearing at the Court of Appeals, was evasive in answering questions on whether his office undertook the necessary evaluation on the possible environmental impact of Bt talong field trials and the release of GMOs into the environment in general. He later admitted that the EMB actually lacked the competence and budget to conduct an environmental impact assessment of Bt eggplants.  

His statement is an indication of the EMB-DENR’s lack of serious attention to its mandate under Section 4.9 of EO 514, i.e., as the primary government agency responsible for the conservation, management, development and proper use of the country’s environment and natural resources, the DENR shall ensure that environmental assessments are done and impacts identified in biosafety decisions. It also is to take the lead in evaluating and monitoring regulated articles intended for bio-remediation, the improvement of forest genetic resources, and wildlife genetic resources. 

On the supposed absence of budget mentioned by Atty. Segui, EO 514 itself directs the concerned agencies to ensure that there will be funding for the implementation of the NBF as it was intended to be a multi-disciplinary effort involving different government departments and agencies. Section 6 of EO 514 states that “the DOST, DENR, DA and DOH shall allocate funds from their present budgets to implement the NBF, including support to the operations of the National Committee on Biosafety of the Philippines (NCBP) and its Secretariat. Starting 2006 and thereafter, the funding requirements shall be included in the General Appropriations Bill submitted by each of the said departments to Congress.[xxiv] 

Based on the above-mentioned points, the SC concluded that the EMB had clearly failed to fulfil its mandate in the implementation of the NBF. 

Application of the Precautionary Principle 

The SC affirmed the conclusion of the CA that the Precautionary Principle set forth in Section 1, Rule 20 of the Rules of Procedure for Environment Cases[xxv] found relevance in the present controversy. In its decision, the SC quoted an annotation to the Rules of Procedure for Environment Cases that the Precautionary Principle finds direct application in the evaluation of evidence in cases before the courts.  

The principle bridges the gap in cases where scientific certainty in factual findings cannot be achieved. By applying the Precautionary Principle, the court may construe a set of facts as warranting either judicial action or inaction, with the goal of preserving and protecting the environment. It therefore leans towards protecting the constitutional right of the people to a balanced and healthful ecology. In effect, the Precautionary Principle shifts the burden of evidence of harm away from those likely to suffer harm and onto those desiring to change the status quo. An application of the Precautionary Principle to the rules on evidence will enable courts to tackle future environmental problems before ironclad scientific consensus emerges.[xxvi] 

For purposes of evidence, the Precautionary Principle should be treated as a principle of last resort, where the application of the regular rules of evidence would cause an inequitable result for the environmental plaintiff i.e., in (a) settings in which the risks of harm are uncertain; (b) settings in which harm might be irreversible and what is lost is irreplaceable; and (c) settings in which the harm that might result would be serious. When these features—uncertainty, the possibility of irreversible harm, and the possibility of serious harm—exist, the case for the application of the Precautionary Principle is strongest. When in doubt, cases must be resolved in favour of the constitutional right to a balanced and healthful ecology.[xxvii] 

After the assessment of the evidence on record as well as the current state of GMO research worldwide, the SC found that all the three conditions were present in the Bt talong case and they were compelling reasons for the application of the Precautionary Principle. It found that there existed a preponderance of evidence that the release of GMOs into the environment threatened to damage ecosystems and not just field testing sites, as well as the health of the Filipino people once the Bt eggplants were consumed as food. Adopting the precautionary approach, the SC decided that the more prudent course was to immediately stop the Bt talong field trials and withdraw approval for its propagation or commercialization until the different government offices had performed their respective mandates to implement the NBF.[xxviii] 

Conclusions 

Due to the above-mentioned fundamental deficiencies, DAO 8-2002 was declared by the Supreme Court of the Philippines as null and void. In its salient parts, it was inconsistent with the basic guidelines provided for in the Constitution, violated binding international obligations contained in the Cartagena Protocol on Biosafety, and effectively disregarded the Executive Orders issued by the President of the Philippines in the field of biodiversity and biosafety.[xxix] In its present form, therefore, DAO 8-2002 could not be used as the guideline to regulate further field testing or commercial propagation of Bt talong. The effect of the SC’s ruling was that until a new law or regulation was passed consistent with the Constitution, treaty obligations, and international laws, no genetically modified ingredients, processes or products could be imported, field tested, or commercially propagated in the Philippines.[xxx] 

On March 7, 2016, however, the Department of Science and Technology (DOST), Department of Agriculture (DA), Department of Environment and Natural Resources (DENR), Department of Health (DOH) and Department of Interior and Local Government (DILG) approved the new Joint Department Circular No. 1, Series of 2016 on Rules and Regulations for the Research and Development, Handling and Use, Transboundary Movement, Release into the Environment, and Management of Genetically-Modified Plant and Plant Products Derived from the Use of Modern Biotechnology. This new Joint Department Circular will allow the issuance of fresh permits for the planting in or importing of genetically modified crops into the Philippines. Thus, the struggle continues to make sure that this new Circular will truly protect the rights of the Filipino people to health and to a balanced and healthful environment, and that it is consistent with the country’s binding international obligations contained in the Cartagena Protocol on Biosafety.