Understanding the Challenges brought about by

Part 1: General Provisions Section 2: Coverage
Scope – This Order covers the importation or release into the environment of:
1. Any plant which has been altered or produced through the use of modern biotechnology if the donor organism, host organism, or vector or vector agent belongs to any of the genera or taxa classified by BPI as meeting the definition of plant pest or is a medium for the introduction of noxious weeds; or
2. Any plant or plant product altered or produced through the use of modern biotechnology which may pose significant risks to human health and the environment based on available scientific and technical information. B. Exceptions. - This Order shall not apply to the contained use of a regulated article, which is within the regulatory supervision of NCBP.<br>

Part 1: General Provisions Section 3: Risk Assessment
A. Principles of Risk Assessment - No regulated article shall be allowed to be imported or released into the environment without the conduct of a risk assessment performed in accordance with this Order. The following principles shall be followed when performing a risk assessment to determine whether a regulated article poses significant risks to human health and the environment: 1. The risk assessment shall be carried out in a scientifically sound and transparent manner based on available scientific and technical information. The expert advice of, and guidelines developed by, relevant international organizations and regulatory authorities of countries with significant experience in the regulatory supervision of the regulated article shall be taken into account in the conduct of risk assessment.<br>

Part 1: General Provisions Section 1: Definition of Terms
L. "IBC" means the Institutional Biosafety Committee established by an applicant in preparation for the field testing of a regulated article and whose membership has been approved by BPI. The JBC shall be responsible for the initial evaluation of the risk assessment and risk management strategies of the applicant for field testing. It shall be composed of at least five (5) members, three (3) of whom shall be designated as "scientist-members" who shall possess scientific and technological knowledge and expertise sufficient to enable them to evaluate and monitor properly any work of the applicant relating to the field testing of a regulated article. The other members, who shall be designated as "community representatives", shall not be affiliated with the applicant apart from being members of its IBC and shall be in a position to represent the interests of the communities where the field testing is to be conducted. For the avoidance of doubt, NCBP shall be responsible for approving the membership of the IBC for contained use of a regulated article.<br>

Part 1: General Provisions Section 1: Definition of Terms
EE. "STRP" means the Scientific and Technical Review Panel created by BPI as an advisory body, composed of at least three (3) reputable and independent scientists who shall not be employees of the Department and who have the relevant professional background necessary to evaluate the potential risks of the proposed activity to human health and the environment based on available scientific and technical information.<br>

Part III: Approval Process for Field Testing of Regulated Articles Section 8: Requirements for Field Testing
G. Public Consultation. - The applicant, acting through its IBC, shall notify and invite comments on the field testing proposal from the barangays and city/municipal governments with jurisdiction over the field test sites. The IBC shall post for three (3) consecutive weeks copies of the Public Information Sheet for Field Testing approved by the BPI in at least three (3) conspicuous places in each of the concerned barangay and city/municipal halls. The Public Information Sheet for Field Testing shall, among others, invite interested parties to send their comments on the proposed field testing to BPI within a period of thirty (30) days from the date of posting. It shall be m a language understood in the community. During the comment period, any interested person may submit to BPI written comments regarding the application. The applicant shall submit proof of posting in the form of certifications from the concerned barangay captains and city/municipal mayors or an affidavit stating the dates and places of posting duly executed by the responsible officer or his duly authorized representative.<br>

SUPREME COURT DECISION: FIRST WAVE Declaring DAO 08-2002 Unconstitutional and Stopped the field testing of Bt Talong

December 8, 2015<br>

Factual Background 1979, establishment of the National Institute for Applied Microbiology and Biotechnology. 1990, EO430 created the National Committee on Biosafety of the Philippines 1991, Philippine Biosafety Guidelines was formulated by NCBP December 23, 1993, the Convention on Biological Diversity came into force. January 2000, An agreement was reached on the Cartagena Protocol on Biosafety. In May 2000, the Philippines signed the Cartagena Protocol which came into force on September 11, 2003. On August 14, 2006, The Senate adopted the Cartagena Protocol. April 2002, Department of Agriculture issued Department Administrative Order (DAO) No. 08-2002 March 17, 2006, Executive Order No. 514 was issued. On September 24, 2010, A Memorandum of Undertaking (MOU) was executed between UPLBFI, ISAAA, and UP Mindanao Foundation, Inc.<br>

Factual Background 2007, Contained experiment was started under the regulatory supervision of NCBP and was completed on March 3, 2009. BPI issued Biosafety Permits to UPLB on March 16, 2010 and June 28, 2010. On April 26, 2012, Greenpeace, MASIPAG and individual respondents filed a petition for Writ of Kalaikasan and Writ of Continuing Mandamus with prayer for the issuance of TEPO. May 17, 2013, CA rendered a decision granting the petition and directing the respondents to cease and desist from further conducting Bt Talong Field Trials and Protect Preserve, Rehabilitate and Restore the environment. May 2, 2012, The SC issued the Writ of Kalikasan against ISAAA, EMB/BPI/FPA, and UPLB July 10, 2012, The SC referred the case to CA for hearing, reception of evidence and rendition of judgment.<br>

NOTE: Field Testing was terminated August 10, 2012 March 16, 2010 and June 28, 2010 – BPI issued a two-year biosafety permit for field testing of Bt Talong.<br>

ISSUES Whether or not respondents have legal standing. Whether or not the case is already moot. Whether or not respondents violated the doctrines of Primary Jurisdiction and Exhaustion of Administrative Remedies. Whether or not respondents the law on EIS/EIA on projects involving the introduction and propagation of GMOs in the country is applicable.. Whether or not respondents have duly established by evidence the damage or threat of damage to human health and environment in two or more provinces, as a result of the Bt Talong field trials. Whether or not there was neglect or unlawful omission on the part of the public petitioners in connection with the processing and evaluation of the applications for Bt Talong field testing; Whether or not the Precautionary Principle is applicable.<br>

First Issue: LEGAL STANDING YES. The Petitioners have legal standing to file the petition for Writ o Kalikasan and Writ of Continuing Mandamus. The Court liberally applied the rule on Locus Standi applying the case of Oposa vs. Facturan.<br>

Second Issue: MOOTNESS NO. As a general rule, once a case becomes moot and academic, the court cannot rule on the facts and issues of the case as it no longer present a justiciable controversy. However, this rule admits for exceptions. In this case, “the presence of the second and fourth exceptions justified the CA in not dismissing the case despite the termination of Bt talong field trials”.<br>

Third Issue: VIOLATION OF THE PJ AND EAR NO. The doctrine of exhaustion of administrative remedies and its corollary doctrine of primary jurisdiction, which are based on sound public policy and practical considerations, are not inflexible rules. There are many accepted exceptions. One of which is when “there is no other plain, speedy, and adequate remedy.” Clearly, the provisions of DAO 08-2002 do not provide a speedy, or adequate remedy for the respondents "to determine the questions of unique national and local importance raised here that pertain to laws and rules for environmental protection, thus [they were] justified in coming to this Court."50 We take judicial notice of the fact that genetically modified food is an intensely debated global issue, and despite the entry of GMO crops (Bt corn) into the Philippines in the last decade, it is only now that such controversy involving alleged damage or threat to human health and the environment from GMOs has reached the courts.<br>

Fourth and Fifth Issue: Applicability Of EIS/EIA And Neglect And Unlawful Omission On The Part Of The Public Petitioners. Role of Environmental Impact Assessment. - The application of the EIA System to biosafety decisions shall be determined by concerned departments and agencies subject to the requirements of law and the standards set by the NCBP. Where applicable and under the coordination of the NCBP, concerned departments and agencies shall issue joint guidelines on the matter. (Emphasis supplied) – DAO 08-2002 petitioners simply adhered to the procedures laid down by DAO 08-2002 and no real effort was made to operationalize the principles of the NBF in the conduct of field testing of Bt talong. The failure of DAO 08-2002 to accommodate the NBF means that the Department of Agriculture lacks mechanisms to mandate applicants to comply with international biosafety protocols.<br>

Even without the issuance of EO 514, GMO field testing should have at least been considered for EIA under existing regulations of petitioner EMB on new and emerging technologies, to wit:
g.) Group V (Unclassified Projects): These are the projects not listed in any of the groups, e.g. projects using new processes/technologies with uncertain impacts. This is an interim category - unclassified projects will eventually be classified into their appropriate groups after EMB evaluation.137 (Emphasis supplied) Fourth and Fifth Issue: Applicability Of EIS/EIA And Neglect And Unlawful Omission On The Part Of The Public Petitioners. The foregoing of the EMB's Chief of the Legal Division is an indication of the DENR-EMB's lack of serious attention to their mandate under the law in the implementation of the NBF, as provided in the following sections of EO 514: 
4.9 Mandate of the Department of Environment and Natural Resources. - As the primary government agency responsible for the conservation, management, development and proper use of the country's environment and natural resources, the Department of Environment and Natural Resources (DENR) shall ensure that environmental assessments are done and impacts identified in biosafety decisions. It shall also take the lead in evaluating and monitoring regulated articles intended for bioremediation, the improvement of forest genetic resources, and wildlife genetic resources<br>

Sixth Issue: EVIDENCE OF DAMAGE OR THREAT OF DAMAGE TO HEALTH AND ENVIRONMENT current scientific research indicates that the biotech industry has not sufficiently addressed the uncertainties over the safety of GM foods and crops.<br>

Seventh Issue: APPLICABILITY OF PRECAUTIONARY PRINCIPLE YES. The Precautionary Principle finds application. SEC. 1. Applicability. - When there is a lack of full scientific certainty in establishing a causal link between human activity and environmental effect, the court shall apply the precautionary principle in resolving the case before it. The constitutional right of the people to a balanced and healthful ecology shall be given the benefit of the doubt. SEC. 2. Standards for application. - In applying the precautionary principle, the following factors, among others, may be considered: (1) threats to human life or health; (2) inequity to present or future generations; or (3) prejudice to the environment without legal consideration of the environmental rights of those affected.<br>

Under this Rule, the precautionary principle finds direct application in the evaluation of evidence in cases before the courts. The precautionary 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. This may be further evinced from the second paragraph where bias is created in favor of 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. Seventh Issue: APPLICABILITY OF PRECAUTIONARY PRINCIPLE<br>

Alongside the aforesaid uncertainties, the non-implementation of the NBF in the crucial stages of risk assessment and public consultation, including the determination of the applicability of the EIS requirements to GMO field testing, are compelling reasons for the application of the precautionary principle. There exists a preponderance of evidence that the release of GMOs into the environment threatens to damage our ecosystems and not just the field trial sites, and eventually the health of our people once the Bt eggplants are consumed as food. Adopting the precautionary approach, the Court rules that the principles of the NBF need to be operationalized first by the coordinated actions of the concerned departments and agencies before allowing the release into the environment of genetically modified eggplant. The more prudent course is to immediately enjoin the Bt talong field trials and approval for its propagation or commercialization until the said government offices shall have performed their respective mandates to implement the NBF Seventh Issue: APPLICABILITY OF PRECAUTIONARY PRINCIPLE<br>

THUS, The conduct of the assailed field testing for Bt talong is hereby PERMANENTLY ENJOINED; Department of Agriculture Administrative Order No. 08, series of 2002 is declared NULL AND VOID; and Consequently, any application for contained use, field testing, propagation and commercialization, and importation of genetically modified organisms is TEMPORARILY ENJOINED until a new administrative order is promulgated in accordance with law.<br>

JDC No. 08-2016,A.SC 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<br>

Article I: General Provisions Section 1. Applicability. This Joint Department Circular shall apply to the research, 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, included under "regulated articles."<br>

The principles under the NBF shall guide concerned agencies in making biosafety decisions, including: Article II: Biosafety Decisions A. Standard of Precaution. Lack of scientific certainty or consensus due to insufficient relevant scientific information and knowledge regarding the extent of the potential adverse effects of a genetically modified organism on the environment, particularly on the conservation and sustainable use of biological diversity, and on human health, shall not prevent concerned government departments and agencies from making the appropriate decision to avoid or minimize such potential adverse effects. In such cases, concerned government departments and agencies shall take the necessary action to protect public interest and welfare.<br>

Article II: Biosafety Decisions B. Risk Assessment. Risk assessment shall be mandatory and central in making biosafety decisions, consistent with policies and standards on risk assessment issued by the NCBP; and guided by Annex III of the Cartagena Protocol on Biosafety. Pursuant to the NBF, the following principles shall be followed when performing a risk assessment to determine whether a regulated article poses significant risks to human health and the environment. 1. The risk assessment shall be carried out in a scientifically sound and transparent manner based on available scientific and technical information. The expert advice of and guidelines developed by, relevant international organizations, including intergovernmental bodies, and regulatory authorities of countries with significant experience in the regulatory supervision of the regulated article shall be taken into account. In the conduct of risk assessment, CODEX Alimentarius Guidelines on the Food Safety Assessment of Foods Derived from the Recombinant-DNA Plants shall internationally adopted as well as other internationally accepted consensus documents.<br>

Article III: Administrative Framework A. [DA]. As the principal agency of the Philippine Government responsible for the promotion of agricultural and rural growth and development so as to ensure food security and to contribute to poverty alleviation, the DA shall take the lead in addressing biosafety issues related to the country's agricultural productivity and food security. x x x. Section 4. Role of National Government Agencies Consistent with the NBF and the laws granting their powers and functions, national government agencies shall have the following roles: B. [DOST]. As the premier science and technology body in the country, the DOST shall take the lead in ensuring that the best available science is utilized and applied in adopting biosafety policies, measures and guidelines, and in making biosafety decision.<br>

Article III: Administrative Framework C. [DENR]. 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. x x x. E. [DILG]. The DILG shall coordinate with the DA, DOST, DENR and DOH in overseeing the implementation of this Circular in relation to the activities that are to be implemented in specific LGUs, particulady in relation to the conduct of public consultations as required under the Local Government Code. x x x.<br>

Section 6. Institutional Biosafety Committee
The company or institution applying for and granted permits under this Circular shall constitute an IBC prior to the contained use, confined test, or field trial of a regulated article. The membership of the IBC shall be approved by the DOST-BC for contained use or confined test, or by the DA-BC for field trial. The IBC is responsible for the conduct of the risk assessment and preparation of risk management strategies of the applicant for contained use, confined test, or field trial. It shall make sure that the environment and human health are safeguarded in the conduct of any activity involving regulated articles.
The IBC shall be composed of at least five (5) members, three (3) of whom shall be designated, as scientist-members and two (2) members shall be community representatives. All scientist-members must possess scientific or technological knowledge and expertise sufficient to enable them to property evaluate and monitor any work involving regulated articles conducted by the applicant.
The community representative must not be affiliated with the applicant, and must be in a position to represent the interests of the communities where the activities are to be conducted. One of the community representatives shall be an elected official of the LGU. The other community representative shall be selected from the residents who are members of the Civil Society Organizations represented in the Local Poverty Reduction Action Team, pursuant to DILG Memorandum Circular No. 2015-45. For multi-location trials, community representatives of the IBC shall be designated per site. x x x. (Underscoring supplied) Article III: Administrative Framework<br>

Section 7. Scientific and Technical Review Panel (STRP) The DA shall create a Scientific and Technical Review Panel composed of a pool of non-DA scientists with expertise in the evaluation of the potential risks of regulated articles to the environment and health. x x x
The DA shall select scientists/experts in the STRP, who shall meet the following qualifications:
A. Must not be an official, staff or employee of the DA or any of its attached agencies;
B. Must not be directly or indirectly employed or engaged by a company or institution with pending applications for permits covered by this Circular;
C. Possess technical expertise in at least one of the following fields: food and nutrition; toxicology, ecology, crop protection, environmental science, molecular biology and biotechnology, genetics, plant breeding, animal nutrition; and
D. Well-respected in the scientific community as evidenced by positions held in science-based organizations, awards and recognitions, publications in local and international peer-reviewed scientific journals. Article III: Administrative Framework<br>

Section 12. Public Participation for Field Trial [vis-à-vis Section 3(F), Article II]
A. The BPI shall make public all applications and Biosafety Permits for Field Trial through posting on the NCBP and BPI websites, and in the offices of the DA and DOST in the province, city, or municipality where the field trial will be conducted. Article V: Field Trial of Regulated Articles B. Upon completion of the STRP, DOH-BC and DENR-BC evaluation, the IBC, in consultation with the City/Municipal Local Government Operations Officer (C/MLGOO), shall inform the local chief executive, through written correspondence, of the proposed field trials to be conducted in the LGU, together with a request to conduct a public hearing. The letter shall include a copy of the PIS for field trial approved by the BPI and the consolidated risk assessment reports.<br>

C. With the consent of the LGU(s), the IBC, in consultation with the C/MLGOO, shall post notices, in the language understood by the local community, and containing copies of the PIS for field trial approved by the BPI and the consolidated risk assessment report, in at least three (3) conspicuous places within the vicinity of the city/municipality and barangay where the proposed field trials will be conducted at least two (2) weeks prior to the public hearing. The notices shall, among others, invite interested parties to send their comments on the proposed field trial to the BPI within the posting period, and to attend the public hearing. During the comment period, any interested person may submit to the BPI written comments regarding the application. Article V: Field Trial of Regulated Articles<br>

Article V: Field Trial of Regulated Articles D. The applicant, thru their IBC, in consultation with the DA-BC and the C/MLGOO, shall convene the public hearing for purposes of consulting stakeholders, particularly local government officials and functionaries, local communities, indigenous peoples, the Agricultural and Fisheries Council and the Protected Area Management Board, where applicable, in the area where the field trials are to be conducted. E. The applicant shall submit to the BPI a written report on the public consultation containing the following: (1) summary of issues and comments raised during the posting period and public hearing, and addressing them point-by-point; and (2) the approval of the Sanggunian concerned pursuant to Sec. 27 of the Local Government Code. If the applicant fails to secure the LGU endorsement within the required period of submitting the report, the applicant may request for extension of time to secure the LGU endorsement.<br>

Article V: Field Trial of Regulated Articles Section 14. Environmental and Health Impact Assessment. On the basis of the Project Description and risk assessment conducted by the IBC, the DENR-BC shall assess the environmental impact of the project and make its recommendations in its report to the BPI. The DOH-BC shall likewise evaluate the application for its health impacts and make its recommendations in its report to the BPI. [vis-à-vis Section 3(C), Article II]<br>

SUPREME COURT DECISION: FINAL WAVE Reversing the decision dated December 8, 2015

July 26, 2016<br>

Facts of the Case: A nine (9) Motion for Reconsiderations were filed before the Supreme Court asking the Court to reconsider its decision dated December 8, 2005 Issues Raised: Whether or not the SC should have dismissed the case for mootness in view of the completion and termination of the Bt talong field trials and the expiration of the Biosafety Permits; and Whether or not the SC should not have ruled on the validity of DAO 08-2002 since it was not raised as an issue in the case.<br>

First Issue: MOOTNESS YES. The Court should have dismissed the case on the ground of mootness. On the paramount public interest exception: Jurisprudence in this jurisdiction has set no hard-and-fast rule in determining whether a case involves paramount public interest in relation to the mootness principle. However, a survey of cases would show that, as a common guidepost for application, there should be some perceivable benefit to the public which demands the Court to proceed with the resolution of otherwise moot questions. In this case, there was no perceivable benefit to the public - whether rational or practical - may be gained by resolving respondents' petition for Writ of Kalikasan on the merits. To recount, these cases, which stemmed from herein respondents petition for Writ of Kalikasan, were mooted by the undisputed expiration of the Biosafety Permits issued by the BPI and the completion and termination of the Bt talong field trials subject of the same. These incidents effectively negated the necessity for the reliefs sought by respondents in their petition for Writ of Kalikasan as there was no longer any field test to enjoin. Hence, at the time the CA rendered its Decision dated May 17, 2013, the reliefs petitioner sought and granted by the CA were no longer capable of execution.<br>

NOTE, however, that the completion and termination of the field tests do not mean that herein petitioners may inevitably proceed to commercially propagate Bt talong.<br>

As the matter never went beyond the field testing phase, none of the foregoing tasks related to propagation were pursued or the requirements therefor complied with. Thus, there are no guaranteed after-effects to the already concluded Bt talong field trials that demand an adjudication from which the public may perceivably benefit. Any future threat to the right ,of herein respondents or the public in general to a healthful and balanced ecology is therefore more imagined than real. The Court further ruled that;<br>

First Issue: MOOTNESS The case is not one capable of repetition yet evading review: The Court notes that the petition for Writ of Kalikasan specifically raised issues only against the field testing of Bt talong under the premises 'of DAO 08-2002, i.e., that herein petitioners failed to: (a) fully inform the people regarding the health, environment, and other hazards involved; and (b) conduct any valid risk assessment before conducting the field trial. As further pointed out by Justice Leonen, the reliefs sought did not extend far enough to enjoin the use of the results of the field trials that have been completed. Hence, the petition's specificity prevented it from falling under the above exception to the mootness rule. More obviously, the supersession of DAO 08-2002 by JDC 01-2016 clearly prevents this case from being one capable of repetition so as to warrant review despite its mootness. To contextualize, JDC 01-2016 states that: Section 1. Applicability. This Joint Department Circular shall apply to the research, 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 technology, included under "regulated articles."<br>

First Issue: MOOTNESS Notably, the new framework under JDC 01-2016 is substantially different from that under DAO 08-2002. In fact, the new parameters in JDC 01-2016 pertain to provisions which prompted the Court to invalidate D'AO 08-2002. In the December 8, 2015 Decision of the Court, it was observed that: (a) DAO 08-2002 has no mechanism to mandate compliance with inten1ational biosafety protocols; (b) DAO 08-2002 does not comply with the transparency and public participation requirements under the NBF; and (c) risk assessment is conducted by an informal group, called the Biosafety Advisory Team of the DA, composed of representatives from the BPI, Bureau of Animal Industry, FPA, DENR, DOH, and DOST. it is apparent that the regulatory framework now applicable in conducting risk assessment in matters involving the research, development, handling, movement, and release into the environment of genetically modified plant and plant products derived from the use of modem biotechnology is substantially different from that which was applied to the subject field trials. In this regard, it cannot be said that the present case is one capable of repetition yet evading review. At this point, the Court discerns that there are two (2) factors to be considered before a case is deemed one capable of repetition yet evading review: (1) the challenged action was in its duration too short to be fully litigated prior to its cessation or expiration; and (2) there was a reasonable expectation that the same complaining party would be subjected to the same action<br>

Second Issue: VALIDITY OF DAO 08-2002 NO. The Court should not have on the validity of the DAO 08-2002. it was merely collaterally challenged by respondents, based on the constitutional precepts of the people's rights to information on matters of public concern, to public participation, to a balanced and healthful ecology, and to health. In fact, respondents merely prayed for its amendment, as well as that of the NBF, to define or incorporate "an independent, transparent, and comprehensive scientific and socio-economic risk assessment, public information, consultation, and participation, and providing for their effective implementation, in accord with international safety standards." Thus, The court granted the Motion for Reconsideration;
Set-aside the decision of the Court of Appeals; and
A new one is entered dismissing the petition for the writ of continuing mandamus and writ of kalikasan with prayer for the issuance of TEPO.<br>

THE END!<br>