International Service For The Acquisition of Agri-Biotech Applications, Inc. V Greenpeace Southeast Asia (Philippines)
International Service For The Acquisition of Agri-Biotech Applications, Inc. V Greenpeace Southeast Asia (Philippines)
International Service For The Acquisition of Agri-Biotech Applications, Inc. V Greenpeace Southeast Asia (Philippines)
DECISION
VILLARAMA, JR., J.:
The consolidated petitions before Us seek the reversal of the Decision1 dated May 17,
2013 and Resolution2 dated September 20, 2013 of the Court of Appeals (CA) in CA-
G.R. SP No. 00013 which permanently enjoined the conduct of field trials for genetically
modified eggplant.
The Parties
The University of the Philippines Los Bafios (UPLB) is an autonomous constituent of the
University of the Philippines (UP), originally established as the UP College of Agriculture.
It is the center of biotechnology education and research in Southeast Asia and home to
at least four international research and extension centers. Petitioner UPLB Foundation,
Inc. (UPLBFI) is a private corporation organized "to be an instrument for
institutionalizing a rational system of utilizing UPLB expertise and other assets for
generating additional revenues and other resources needed by [UPLB]". Its main
purpose is to assist UPLB in "expanding and optimally utilizing its human, financial, and
material resources towards a focused thrust in agriculture, biotechnology, engineering
and environmental sciences and related academic programs and activities." A
memorandum of agreement between UPLBFI and UPLB allows the former to use
available facilities for its activities and the latter to designate from among its staff such
personnel needed by projects.5
The other individual respondents are Filipino scientists, professors, public officials and
ordinary citizens invoking their constitutionally guaranteed right to health and balanced
ecology, and suing on their behalf and on behalf of future generations of Filipinos.
Factual Background
In 1979, President Ferdinand Marcos approved and provided funding for the
establishment of the National Institute for Applied Microbiology and Biotechnology
(BIOTECH) at UPLB. It is the premier national research and development (R & D)
institution applying traditional and modern biotechnologies in innovating products,
processes, testing and analytical services for agriculture, health, energy, industry and
development.9
In 1990, President Corazon C. Aquino signed Executive Order (EO) No. 430 creating the
National Committee on Biosafety of the Philippines (NCBP). NCBP was tasked, among
others, to "identify and evaluate potential hazards involved in initiating genetic
engineering experiments or the introduction of new species and genetically engineered
organisms and recommend measures to minimize risks" and to "formulate and review
national policies and guidelines on biosafety, such as the safe conduct of work on
genetic engineering, pests and their genetic materials for the protection of public
health, environment and personnel and supervise the implementation thereof."
In 1991, NCBP formulated the Philippine Biosafety Guidelines, which governs the
regulation of the importation or introduction, movement and field release of potentially
hazardous biological materials in the Philippines. The guidelines also describe the
required physical and biological containment and safety procedures in handling
biological materials. This was followed in 1998 by the "Guidelines on Planned Release of
Genetically Manipulated Organisms (GMOs) and Potentially Harmful Exotic
Species (PHES)."10
On December 29, 1993, the Convention on Biological Diversity (CBD) came into force.
This multilateral treaty recognized that "modern biotechnology has great potential for
human well-being if developed and used with adequate safety measures for the
environment and human health." Its main objectives, as spelled out in Article 1, are the
"conservation of biological diversity, the sustainable use of its components and the fair
and equitable sharing of the benefits arising out of the utilization of genetic resources."
On May 24, 2000, the Philippines signed the Cartagena Protocol, which came into force
on September 11, 2003. On August 14, 2006, the Philippine Senate adopted Senate
Resolution No. 92 or the "Resolution Concurring in the Ratification of the Cartagena
Protocol on Biosafety (CPB) to the UN Convention on Biological Diversity."
In April 2002, the Department of Agriculture (DA) issued DA-Administrative Order (AO)
No. 08 providing rules and regulations for the importation and release into the
environment of plants and plant products derived from the use of modem
biotechnology.
DAO-08-2002 covers the importation or release into the environment of: (1) any plant
which has been altered or produced through the use of modem biotechnology if the
donor organism, host organism, or vector or vector agent belongs to the genera or taxa
classified by the Bureau of Plant Industry (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 through the use of modem biotechnology which may pose significant risks to
human health and the environment based on available scientific and technical
information.
The country's biosafety regulatory system was further strengthened with the issuance
of EO No. 514 (EO 514) on March 17, 2006, "Establishing the National Biosafety
Framework (NBF), Prescribing Guidelines for its Implementation, and Strengthening the
NCBP." The NBF shall apply to the development, adoption and implementation of all
biosafety policies, measures and guidelines and in making decisions concerning the
research, development, handling and use, transboundary movement, release into the
environment and management of regulated articles.12
Under the regulatory supervision of NCBP, a contained experiment was started in 2007
and officially completed on March 3, 2009. The NCBP thus issued a Certificate of
Completion of Contained Experiment stating that "During the conduct of the
experiment, all the biosafety measures have been complied with and no untoward
incident has occurred."16
BPI issued Biosafety Permits17 to UPLB on March 16, 2010 and June 28, 2010.
Thereafter, field testing of Bt talong commenced on various dates in the following
approved trial sites: Kabacan, North Cotabato; Sta. Maria, Pangasinan; Pili, Camarines
Sur; Bago Oshiro, Davao City; and Bay, Laguna.
Greenpeace, et al. further claimed that the Bt talong field test project did not comply
with the required public consultation under Sections 26 & 27 of the Local Government
Code, A random survey by Greenpeace on July 21, 2011 revealed that ten households
living in the area immediately around the Bt talong experimental farm in Bay, Laguna
expressed lack of knowledge about the field testing in their locality. The Sangguniang
Barangay of Pangasugan in Baybay, Leyte complained about the lack of information on
the nature and uncertainties of the Bt talong field testing in their barangay. The Davao
City Government likewise opposed the project due to lack of transparency and public
consultation. It ordered the uprooting of Bt eggplants at the trial site and disposed
them strictly in accordance with protocols relayed by the BPI through Ms. Merle
Palacpac. Such action highlighted the city government's policy on "sustainable and safe
practices." On the other hand, the Sangguniang Bayan of Sta. Barbara, Iloilo passed a
resolution suspending the field testing due to the following: lack of public consultation;
absence of adequate study to determine the effect of Bt talong field testing on friendly
insects; absence of risk assessment on the potential impacts of genetically modified
(GM) crops on human health and the environment; and the possibility of cross-
pollination of Bt eggplants with native species or variety of eggplants, and serious
threat to human health if these products were sold to the market.
Greenpeace, et al. argued that this case calls for the application of the precautionary
principle, the Bt talong field testing being a classic environmental case where scientific
evidence as to the health, environmental and socio-economic safety is insufficient or
uncertain and preliminary scientific evaluation indicates reasonable grounds for concern
that there are potentially dangerous effects on human health and the environment.
b. Upon the filing [of this petition], issue a writ of continuing mandamus commanding:
(i) Respondents to submit to and undergo the process of environmental impact
statement system under the Environmental Management Bureau;
(iii) Respondents to submit all its issued certifications on public information, public
consultation, public participation, and consent of the local government units in the
barangays, municipalities, and provinces affected by the field testing of Bt talong;
(v) Respondent BPI of the DA, in coordination with relevant government agencies, to
conduct balanced nationwide public information on the nature of Bt talong and Bt
talong field trial, and a survey of social acceptability of the same.
c. Upon filing [of this petition], issue a writ of kalikasan commanding Respondents to
file their respective returns and explain why they should not be judicially sanctioned for
violating or threatening to violate or allowing the violation of the above-enumerated
laws, principles, and international principle and standards, or committing acts, which
would result into an environmental damage of such magnitude as to prejudice the life,
health, or property of petitioners in particular and of the Filipino people in general.
d. After hearing and judicial determination, to cancel all Bt talong field experiments that
are found to be violating the abovementioned laws, principles, and international
standards; and recommend to Congress curative legislations to effectuate such
order.18
ChanRoblesVirtualawlibrary
On May 2, 2012, the Court issued the writ of kalikasan against ISAAA, Environmental
Management Bureau (EMB)/BPI/Fertilizer and Pesticide Authority (FPA) and UPLB,18-
a
ordering them to make a verified return within a non-extendible period often (10)
days, as provided in Sec. 8, Rule 7 of the Rules of Procedure for Environmental Cases.19
ISAAA, EMB/BPI/FPA, UPLBFI and UPMFI filed their respective verified returns. They all
argued that the issuance of writ of kalikasan is not proper because in the
implementation of the Bt talong project, all environmental laws were complied with,
including public consultations in the affected communities, to ensure that the people's
right to a balanced and healthful ecology was protected and respected. They also
asserted that the Bt talong project is not covered by the Philippine Environmental
Impact Statement (PEIS) Law and that Bt talong field trials will not significantly affect
the quality of the environment nor pose a hazard to human health. ISAAA contended
that the NBF amply safeguards the environment policies and goals promoted by the
PEIS Law. On its part, UPLBFI asserted that there is a "plethora of scientific works and
literature, peer-reviewed, on the safety of Bt talong for human consumption."20 UPLB,
which filed an Answer21 to the petition before the CA, adopted said position of UPLBFI.
ISAAA argued that the allegations regarding the safety of Bt talong as food are
irrelevant in the field trial stage as none of the eggplants will be consumed by humans
or animals, and all materials that will not be used for analyses will be chopped, boiled
and buried following the Biosafety Permit requirements. It cited a 50-year history of
safe use and consumption of agricultural products sprayed with commercial Bt microbial
pesticides and a 14-year history of safe consumption of food and feed derived
from Bt crops. Also mentioned is the almost 2 million hectares of land in the Philippines
which have been planted with Bt corn since 2003, and the absence of documented
significant and negative impact to the environment and human health. The statements
given by scientists and experts in support of the allegations of Greenpeace, et al. on the
safety of Bt corn was also addressed by citing the contrary findings in other studies
which have been peer-reviewed and published in scientific journals.
On the procedural aspect, ISAAA sought the dismissal of the petition for writ
of kalikasan for non-observance of the rule on hierarchy of courts and the allegations
therein being mere assertions and baseless conclusions of law. EMB, BPI and FPA
questioned the legal standing of Greenpeace, et al. in filing the petition for writ
of kalikasan as they do not stand to suffer any direct injury as a result of the Bt
talong field tests. They likewise prayed for the denial of the petition for continuing
mandamus for failure to state a cause of action and for utter lack of merit.
UPMFI also questioned the legal standing of Greenpeace, et al. for failing to allege that
they have been prejudiced or damaged, or their constitutional rights to health and a
balanced ecology were violated or threatened to be violated by the conduct of Bt
talong field trials. Insofar as the field trials in Davao City, the actual field trials at Bago
Oshiro started on November 25, 2010 but the plants were uprooted by Davao City
officials on December 17-18, 2010. There were no further field trials conducted and
hence no violation of constitutional rights of persons or damage to the environment,
with respect to Davao City, occurred which will justify the issuance of a writ
of kalikasan. UPMFI emphasized that under the MOU, its responsibility was only to
handle the funds for the project in their trial site. It pointed out that in the Field Trial
Proposal, Public Information Sheet, Biosafety Permit for Field Testing, and Terminal
Report (Davao City Government) by respondent Leonardo R. Avila III, nowhere does
UPMFI appear either as project proponent, partner or implementing arm. Since UPMFI,
which is separate and distinct from UP, undertook only the fund management of Bt
talong field test project the duration of which expired on July 1, 2011, it had nothing to
do with any field trials conducted in other parts of the country.
Finally, it is argued that the precautionary principle is not applicable considering that
the field testing is only a part of a continuing study being done to ensure that the field
trials have no significant and negative impact on the environment. There is thus no
resulting environmental damage of such magnitude as to prejudice the life, health,
property of inhabitants in two or more cities or provinces. Moreover, the issues raised
by Greenpeace, et al. largely involve technical matters which pertain to the special
competence of BPI whose determination thereon is entitled to great respect and even
finality.
By Resolution dated July 10, 2012, the Court referred this case to the CA for
acceptance of the return of the writ and for hearing, reception of evidence and rendition
of judgment.22
At the preliminary conference held on September 12, 2012, the parties submitted the
following procedural issues: (1) whether or not Greenpeace, et al. have legal standing
to file the petition for writ of kalikasan; (2) whether or not said petition had been
rendered moot and academic by the alleged termination of the Bt talong field testing;
and (3) whether or not the case presented a justiciable controversy.
Under Resolution23 dated October 12, 2012, the CA resolved that: (1) Greenpeace, et
al. possess the requisite legal standing to file the petition for writ of kalikasan; (2)
assuming arguendo that the field trials have already been terminated, the case is not
yet moot since it is capable of repetition yet evading review; and (3) the alleged non-
compliance with environmental and local government laws present justiciable
controversies for resolution by the court.
The CA then proceeded to hear the merits of the case, adopting the "hot-tub" method
wherein the expert witnesses of both parties testify at the same time. Greenpeace, et
al. presented the following as expert witnesses: Dr. Ben Malayang III (Dr. Malayang),
Dr. Charito Medina (Dr. Medina), and Dr. Tushar Chakraborty (Dr. Chakraborty). On the
opposing side were the expert witnesses in the persons of Dr. Reynaldo Ebora (Dr.
Ebora), Dr. Saturnina Halos (Dr. Halos), Dr. Flerida Cariño (Dr. Cariño), and Dr. Peter
Davies (Dr. Davies). Other witnesses who testified were: Atty. Carmelo Segui (Atty.
Segui), Ms. Merle Palacpac (Ms. Palacpac), Mr. Mario Navasero (Mr. Navasero) and Dr.
Randy Hautea (Dr. Hautea).
On November 20, 2012, Biotechnology Coalition of the Philippines, Inc. (BCPI) filed an
Urgent Motion for Leave to Intervene as Respondent.24 It claimed to have a legal
interest in the subject matter of the case as a broad-based coalition of advocates for
the advancement of modern biotechnology in the Philippines.
In its Resolution25 dated January 16, 2013, the CA denied BCPI's motion for
intervention stating that the latter had no direct and specific interest in the conduct
of Bt talong field trials.
On May 17, 2013, the CA rendered a Decision in favor of Greenpeace, et al., as follows:
WHEREFORE, in view of the foregoing premises, judgment is hereby rendered by
us GRANTING the petition filed in this case. The respondents are DIRECTED to: chanRoblesvirtualLawlibrary
(a) Permanently cease and desist from further conducting bt talong field trials; and
(b) Protect, preserve, rehabilitate and restore the environment in accordance with the
foregoing judgment of this Court.
No costs.
SO ORDERED.26 ChanRoblesVirtualawlibrary
The CA found that existing regulations issued by the DA and the Department of Science
and Technology (DOST) are insufficient to guarantee the safety of the environment and
health of the people. Concurring with Dr. Malayang's view that the government must
exercise precaution "under the realm of public policy" and beyond scientific debate, the
appellate court noted the possible irreversible effects of the field trials and the
introduction of Bt talong to the market.
After scrutinizing the parties' arguments and evidence, the CA concluded that the
precautionary principle set forth in Section 1, Rule 20 of the Rules of Procedure for
Environmental Cases27 finds relevance in the present controversy. Stressing the fact
that the "over-all safety guarantee of the bt talong" remains unknown, the appellate
court cited the testimony of Dr. Cariño who admitted that the product is not yet safe for
consumption because a safety assessment is still to be done. Again, the Decision
quoted from Dr. Malayang 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 health and a balanced ecology.
Denying the motions for reconsideration filed by ISAAA, EMB/BPI/FPA, UPLB and
UPLBFI, the CA in its Resolution dated September 20, 2013 rejected the argument of
UPLB that the appellate court's ruling violated UPLB's constitutional right to academic
freedom. The appellate court pointed out that the writ of kalikasan originally issued by
this Court did not stop research on Bt talong but only the particular procedure adopted
in doing field trials and only at this time when there is yet no law in the form of a
congressional enactment for ensuring its safety and levels of acceptable risks when
introduced into the open environment. Since the writ stops the field trials of Bt
talong as a procedure but does not stop Bt talong research, there is no assault on
academic freedom.
The CA then justified its ruling by expounding on the theory that introducing a
genetically modified plant into our ecosystem is an "ecologically imbalancing act." Thus:
We suppose that it is of universal and general knowledge that an ecosystem is a
universe of biotic (living) and non-biotic things interacting as a living community in a
particular space and time. In the ecosystem are found specific and particular biotic and
non-biotic entities which depend on each other for the biotic entities to survive and
maintain life. A critical element for biotic entities to maintain life would be that their
populations are in a proper and natural proportion to others so that, in the given limits
of available non-biotic entities in the ecosystem, no one population overwhelms
another. In the case of the Philippines, it is considered as one of the richest countries in
terms of biodiversity. It has so many plants and animals. It also has many kinds of
other living things than many countries in the world. We do not fully know how all these
living things or creatures interact among themselves. But, for sure, there is a perfect
and sound balance of our biodiversity as created or brought about by God out
of His infinite and absolute wisdom. In other words, every living creature has been
in existence or has come into being for a purpose. So, we humans are not supposed to
tamper with any one element in this swirl of interrelationships among living things in
our ecosystem. Now, introducing a genetically modified plant in our intricate
world of plants by humans certainly appears to be an ecologically imbalancing
act. The damage that it will cause may be irreparable and irreversible.
At this point, it is significant to note that during the hearing conducted by this Court on
November 20, 2012 wherein the testimonies of seven experts were given, Dr. Peter J.
Davies (Ph.D in Plant [Physiology]), Dr. Tuskar Chakraborty (Ph.D in Biochemistry and
Molecular Biology), Dr. Charito Medina (Ph.D in Environmental Biology), Dr. Reginaldo
Ebora (Ph.D in Entomology), Dr. Flerida Cariño (Ph.D in Insecticide Toxicology), Dr. Ben
Malayang (Ph.D in Wildland Resource Science) and Dr. Saturnina Halos (Ph.D in
Genetics) were in unison in admitting that bt talong is an altered plant. x x x
xxxx
Thus, it is evident and clear that bt talong is a technology involving the deliberate
alteration of an otherwise natural state of affairs. It is designed and intended to alter
natural feed-feeder relationships of the eggplant. It is a deliberate genetic
reconstruction of the eggplant to alter its natural order which is meant to eliminate one
feeder (the borer) in order to give undue advantage to another feeder (the humans).
The genetic transformation is one designed to make bt talong toxic to its pests (the
targeted organisms). In effect, bt talong kills its targeted organisms. Consequently, 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) the Filipinos'
constitutional right to a balanced ecology because, in any book and by any
yardstick, it is an ecologically imbalancing event or phenomenon. It is a willful and
deliberate tampering of a naturally ordained feed-feeder relationship in our
environment. It destroys the balance of our biodiversity. Because it violates the
conjunct right of our people to a balanced ecology, the whole constitutional right of our
people (as legally and logically construed) is violated.
Of course, the bt talong's threat to the human health of the Filipinos as of now remains
uncertain. This is because while, on one hand, no Filipinos has ever eaten it yet, and so,
there is no factual evidence of it actually causing acute or chronic harm to any or a
number of ostensibly identifiable perms, on the other hand, there is correspondingly no
factual evidence either of it not causing harm to anyone. However, in a study published
on September 20, 2012 in "Food and Chemical Toxicology", a team of scientists led by
Professor Gilles-Eric Seralini from the University of Caen and backed by the France-
based Committee of Independent Research and Information on Genetic Engineering
came up with a finding that rats fed with Roundup-tolerant genetically modified corn for
two years developed cancers, tumors and multiple organ damage. The seven expert
witnesses who testified in this Court in the hearing conducted on November 20, 2012
were duly confronted with this finding and they were not able to convincingly rebut it.
That is why we, in deciding this case, applied the precautionary principle in granting the
petition filed in the case at bench.
Prescinding from the foregoing premises, therefore, because one conjunct right in the
whole Constitutional guarantee is factually and is undoubtedly at risk, and the other still
factually uncertain, the entire constitutional right of the Filipino people to a balanced
and healthful ecology is at risk. Hence, the issuance of the writ of kalikasan and the
continuing writ of mandamus is justified and warranted.28 (Additional Emphasis
supplied.)
Petitioners' Arguments
II
THE COURT OF APPEALS GRAVELY ERRED IN REFUSING TO DISMISS THE PETITION
FOR WRIT OF CONTINUING MANDAMUS AND WRIT OF KALIKASAN CONSIDERING THAT
THE SAME RAISES POLITICAL QUESTIONS.
B. WORSE, THE COURT OF APPEALS EVEN HELD THAT THERE ARE NO LAWS
GOVERNING THE STUDY, INTRODUCTION AND USE OF GMOS IN THE
PHILIPPINES AND COMPLETELY DISREGARDED E.O. NO. 514 AND DA- AO
08-2002.
III
IV
THE COURT OF APPEALS EXHIBITED BIAS AND PARTIALITY AND PREJUDGED THE
INSTANT CASE WHEN IT RENDERED THE ASSAILED DECISION DATED 17 MAY 2013
AND RESOLUTION DATED 20 SEPTEMBER 2013.
VI
VII
VIII
Petitioners EMB, BPI and FPA, represented by the Office of the Solicitor General (OSG)
assails the CA Decision granting the petition for writ of kalikasan and writ of continuing
mandamus despite the failure of Greenpeace, et al. (respondents) to prove the
requisites for their issuance.
Petitioners contend that while respondents presented purported studies that supposedly
show signs of toxicity in genetically engineered eggplant and other crops, these studies
are insubstantial as they were not published in peer-reviewed scientific journals.
Respondents thus failed to present evidence to prove their claim that the Bt talong field
trials violated environmental laws and rules.
Petitioners aver that there was no damage to human health since no Bt talong will be
ingested by any human being during the field trial stage. Besides, if the results of said
testing are adverse, petitioners will not allow the release of Bt talong to the
environment, in line with the guidelines set by EO 514. The CA thus misappreciated the
regulatory process as approval for field testing does not automatically mean approval
for propagation of the same product. And even assuming that the field trials may
indeed cause adverse environmental or health effects, the requirement of unlawful act
or omission on the part of petitioners or any of the proponents, was still absent.
Respondents clearly failed to prove there was any unlawful deviation from the
provisions of DAO 08-2002. The BPI's factual finding on the basis of risk assessment on
the Bt talong project should thus be accorded respect, if not finality by the courts.
Petitioners likewise fault the CA in giving such ambiguous and general directive for
them to protect, preserve, rehabilitate and restore the environment, lacking in specifics
which only indicates that there was really nothing to preserve, rehabilitate or restore as
there was nothing damaged or adversely affected in the first place. As to the supposed
inadequacy and ineffectiveness of existing regulations, these are all political questions
and policy issues best left to the discretion of the policy-makers, the Legislative and
Executive branches of government. Petitioners add that the CA treads on judicial
legislation when it recommended the re-examination of country's existing laws and
regulations governing studies and research on GMOs.
Petitioner UPLBFI argues that respondents failed to adduce the quantum of evidence
necessary to prove actual or imminent injury to them or the environment as to render
the controversy ripe for judicial determination. It points out that nowhere in the
testimonies during the "hot-tub" presentation of expert witnesses did the witnesses for
respondents claim actual or imminent injury to them or to the environment as a result
of the Bt talong field tests, as they spoke only of injury in the speculative, imagined
kind without any factual basis. Further, the petition for writ of kalikasan has been
mooted by the termination of the field trials as of August 10, 2012.
Against the respondents' bare allegations, UPLBFI submits the following "specific facts
borne by competent evidence on record" (admitted exhibits)31:
118. Since the technology's inception 50 years ago, studies have shown that genetically
modified crops, including Bt talong, significantly reduce the use of pesticides by
farmers in growing eggplants, lessening pesticide poisoning to humans.
119. Pesticide use globally has decreased in the last [14-15] years owing to the use of insect-
resistant genetically modified crops. Moreover, that insect-resistant genetically modified
crops significantly reduce the use of pesticides in growing plants thus lessening
pesticide poisoning in humans, reducing pesticide load in the environment and
encouraging more biodiversity in farms.
120. Global warming is likewise reduced as more crops can be grown.
121. Transgenic Bacillus thuringensis (Bt) cotton has had a major impact on the Australian
cotton industry by largely controlling Lepidopteran pests. To date, it had no significant
impact on the invertebrate community studied.
122. Feeding on CrylAcc contaminated non-target herbivores does not harm predatory
heteropterans and, therefore, cultivation of Bt cotton may provide an opportunity for
conservation of these predators in cotton ecosystems by reducing insecticide use.
123. The Bt protein in Bt corn only affects target insects and that Bt corn pollens do not
negatively affect monarch butterflies.
124. The field trials will not cause "contamination" as feared by the petitioners because flight
distance of the pollinators is a deterrent to cross pollination. Studies reveal that there can
be no cross pollination more than a fifty (50) meter distance.
xxx
x
135. There is a 50 year history of safe use and consumption of agricultural products sprayed
with commercial Bt microbial pesticides and a 14 year history of safe consumption of
food and feed derived from Bt crops.
xxx
x
140. In separate reviews by the European Food Safety Agency (EFSA) and the Food
Standards Australia and New Zealand (FSANZ), the "work" of one Prof. Seralini relied
upon by [respondents] was dismissed as "scientifically flawed", thus providing no
plausible basis to the proposition that Bt talong is dangerous to public health.
141. In a learned treatise by James Clive entitled "Global Status of Commercialized
Biotech/GM Crops: 2011," the Philippines was cited to be the first country in the
ASEAN region to implement a regulatory system for transgenic crops (which includes
DAO 08-[2]002). Accordingly, the said regulatory system has also served as a model for
other countries in the region and other developing countries outside of Asia.
On the precautionary principle, UPLBFI contends that the CA misapplied it in this case.
The testimonial and documentary evidence of respondents, taken together, do not
amount to "scientifically plausible" evidence of threats of serious and irreversible
damage to the environment. In fact, since BPI started regulating GM crops in 2002,
they have monitored 171 field trials all over the Philippines and said agency has not
observed any adverse environmental effect caused by said field trials. Plainly,
respondents failed to show proof of "specific facts" of environmental damage of the
magnitude contemplated under the Rules of Procedure for Environmental Cases as to
warrant sanctions over the Bt talong field trials.
Lastly, UPLBFI avers that the Bt talong field trial was an exercise of the constitutional
liberty of scientists and other academicians of UP, of which they have been deprived
without due process of law. Stressing that a possibility is not a fact, UPLBFI deplores
the CA decision's pronouncement of their guilt despite the preponderance of evidence
on the environmental safety of the field trials, as evident from its declaration that "the
over-all safety guarantee of Bt talong remains to be still unknown." It thus asks if in the
meantime, petitioners must bear the judicial stigma of being cast as violators of the
right of the people to a balanced and healthful ecology for an injury or
damage unsubstantiated by evidence of scientific plausibility.
Petitioner likewise objects to the CA's application of the precautionary principle in this
case, in violation of the standards set by the Rules of Procedure for Environmental
Cases. It points out that the Bt eggplants are not yet intended to be introduced into the
Philippine ecosystem nor to the local market for human consumption.
Cited were the testimonies of two expert witnesses presented before the CA: Dr.
Navasero who is an entomologist and expert in integrated pest management and insect
taxonomy, and Dr. Davies, a member of the faculty of the Department of Plant Biology
and Horticulture at Cornell University for 43 years and served as a senior science
advisor in agricultural technology to the United States Department of State. Both had
testified that based on generally accepted and scientific methodology, the field trial
of Bt crops do not cause damage to the environment or human health.
Contrary to petitioners' claim that they did not violate any law or regulation, or unlawful
omission, respondents assert that, in the face of scientific uncertainties on the safety
and effects of Bt talong, petitioners omitted their crucial duties to conduct
environmental impact assessment (EIA); evaluate health impacts; get the free, prior
and informed consent of the people in the host communities; and provide remedial and
liability processes in the approval of the biosafety permit and conduct of the field trials
in its five sites located in five provinces. These omissions have put the people and the
environment at serious and irreversible risks.
To demonstrate the health hazards posed by Bt crops, respondents cite the following
sources: the studies of Drs. L. Moreno-Fierros, N. Garcia, R. Gutierrez, R. Lopez-Revilla,
and RI Vazquez-Padron, all from the Universidad Nacional Autonoma de Mexico; the
conclusion made by Prof. Eric-Gilles Seralini of the University of Caen, France, who is
also the president of the Scientific Council of the Committee for Independent Research
and Information on Genetic Engineering (CRIIGEN), in his review, commissioned by
Greenpeace, of Mahyco's data submitted in support of the application to grow and
market Bt eggplant in India; and the medical interpretations of Prof. Seralini's findings
by Filipino doctors Dr. Romeo Quijano of the University of the Philippines-Philippine
General Hospital and Dr. Wency Kiat, Jr. of St. Luke's Medical Center (Joint Affidavit).
According to respondents, the above findings and interpretations on serious health risks
are strengthened by the findings of a review of the safety claims in the MAHYCO
Dossier authored by Prof. David A. Andow of the University of Minnesota, an expert in
environmental assessment in crop science. The review was made upon the request in
2010 of His Honorable Shri Jairam Ramesh of the Ministry of Environment and Forests
of India, where MAHYCO is based. MAHYCO is the corporate creator and patent owner
of the Bt gene inserted in Bt talong.
The conclusions of health hazards from the above studies were summarized32 by
respondents, as follows:
Studies/interpretation by Conclusion/interpretation
Drs. L. Moreno-Fierros, N. Garcia, For Bt modified crops (like Bt talong), there is concern
R. Gutierrez, R. over its potential
Lopez-Revilla, and RI Vazquez- allergenicity. CrylAcc (the gene inserted in Bt talong)
Padron protoxin is a potent immunogen (triggers immune
response); the protoxin is immunogenic by both the
intraperitoneal (injected) and intragastric (ingested)
route; the immune response to the protoxin is both
systemic and mucosal; and CrylAcc protoxin binds to
surface proteins in the mouse small intestine. These
suggest that extreme caution is required in the use
of CrylAcc in food crops.
Prof. Eric-Gilles Seralini His key findings showed statistical significant
differences between group of animals fed GM and non-
GM eggplant that raise food safety concerns and
warrant further investigation.
Dr. Romeo Quijano & Dr. Wency Interpreting Prof. Seralini's findings, the altered
Kiat, Jr. condition of rats symptomatically indicate hazards for
human health.
Prof. David A. Andow The MAHYCO dossier is inadequate to support the
needed environmental risk assessment; MAHYCO's
food safety assessment does not comply with
international standards; and that MAHYCO relied on
dubious scientific assumptions and disregarded real
environmental threats.
As to environmental effects, respondents said these include the potential for living
modified organisms, such as Bt talong tested in the field or released into the
environment, to contaminate non-GM traditional varieties and other wild eggplant
relatives and turn them into novel pests, outcompete and replace their wild relatives,
increase dependence on pesticides, or spread their introduced genes to weedy relatives,
potentially creating superweeds, and kill beneficial insects.
In 2005, the European The European Commission The contamination arose
Commission announced that blocked US grain import unless because Syngenta's
illegal Bt10 GEmaize produced they could be guaranteed free of quality control
by GEseed company Syngenta Bt10. The USDA fined Syngenta procedures did not
had entered the European food $375,000. There are no figures for differentiate between
chain. The GEmaize Bt10 the wider costs. Bt10 and its sister
contains a marker gene that commercial line, Bt11.
codes for the widely-used As a result, the
antibiotic ampicillin, while the experimental and
Bt11 does not. According to the substantially different
international Codex Bt10 line was
Alimentarius Guideline for mistakenly used in
Conduct of Food Safety breeding. The error was
Assessment of Foods Derived detected four years later
from Recombinant-DNA:Plants: when one of the seed
'Antibiotic resistance genes used companies developing
in food production that encode Bt11 varieties adopted
resistance to clinically used more sophisticated
antibiotics should not be present analytical techniques.
in foods' because it increases the
risk of antibiotic resistance in
the population.
Refuting the claim of petitioners that contamination is nil or minimal because the scale
of Bt talong field trial is isolated, restricted and that "each experiment per site per
season consists of a maximum net area planted to Bt eggplant of between 480 sq.
meters to 1,080 sq. meters,"34 respondents emphasize that as shown by the above,
contamination knows no size and boundaries in an open environment.
With regard to the required geographical coverage of environmental damage for the
issuance of writ of kalikasan, respondents assert that while the Bt talong field trials
were conducted in only five provinces, the environmental damage prejudicial to health
extends beyond the health of the present generation of inhabitants in those provinces.
On petitioners' insistence in demanding that those who allege injury must prove injury,
respondents said that biosafety evidence could not be readily contained in a corpus
delicti to be presented in court. Indeed, the inherent and potential risks and adverse
effects brought by GMOs are not like dead bodies or wounds that are immediately and
physically identifiable to an eyewitness and which are resulting from a common crime.
Precisely, this is why the Cartagena Protocol's foundation is on the precautionary
principle and development of sound science and its links, to social and human rights law
through its elements of public awareness, public participation and public right to know.
This is also why the case was brought under the Rules of Procedure for Environmental
Cases and not under ordinary or other rules, on the grounds of violation of the rights of
the Filipino people to health, to a balanced and healthful ecology, to information on
matters of national concern, and to participation. The said Rules specifically provides
that the appreciation of evidence in a case like this must be guided by the
precautionary principle.
Finally, on the propriety of the writ of continuing mandamus, respondents argue that
EO 514 explicitly states that the application of biosafety regulations shall be made in
accordance with existing laws and the guidelines therein provided. Hence, aside from
risk assessment requirement of the biosafety regulations, pursuant to the PEISS law
and Sections 12 and 13 of the Philippine Fisheries Code of 1998, an environmental
impact statement (EIS) is required and an environmental compliance certificate (ECC)
is necessary before such Bt crop field trials can be conducted.
Petitioners' Replies
G.R. No. 209271
ISAAA contends that the Precautionary Principle and the Rules of Procedure for
Environmental Cases do not empower courts to adjudicate a controversy that is moot
and academic. It points out that respondents failed to satisfy all the requirements of the
exception to the rule on actual controversies. The Biosafety Permit is valid for only two
years, while the purported stages in the commercialization, propagation and
registration of Bt talong still cannot confer jurisdiction on the CA to decide a moot and
academic case.
As to the propriety of the writ of continuing mandamus, ISAAA maintains that public
petitioners do not have "mandatory" and "ministerial" duty to re-examine and reform
the biosafety regulatory system, and to propose curative legislation. The law (EO 514)
cited by respondents does not impose such duty on public petitioners. As for the
Cartagena Protocol, it laid down a procedure for the evaluation of the Protocol itself, not
of the Philippine biosafety regulatory system. ISAAA stresses that the CA is without
jurisdiction to review the soundness and wisdom of existing laws, policy and
regulations. Indeed, the questions posed by the respondents are political questions,
which must be resolved by the executive and legislative departments in deference to
separation of powers.
ISAAA points out that under Section 7 of DAO 08-2002, the BPI is the approving
authority for field testing permits, while under Title IV, Chapter 4, Section 19 of
the Administrative Code of 1987, the DA through the BPI, is responsible for the
production of improved planting materials and protection of agricultural crops from
pests and diseases. In bypassing the administrative remedies available, respondents
not only failed to exhaust a less costly and speedier remedy, it also deprived the parties
of an opportunity to be heard by the BPI which has primary jurisdiction and
knowledgeable on the issues they sought to raise.
Rejecting the scientific data presented by the respondents, petitioners found Annex "A"
of the Consolidated Comment as irrelevant because it was not formally offered in
evidence and are hearsay. Majority of those records contain incomplete information and
none of them pertain to the Bt talong. Respondents likewise presented two misleading
scientific studies which have already been discredited: the 2013 study by B.P.
Mezzomo, et al. and the study by Prof. Seralini in 2012. Petitioner notes that both
articles have been withdrawn from publication.
ISAAA further describes Annex "A" as a mere compilation of records of flawed studies
with only 126 usable records out of the 338 records. In contrast, petitioner cites the
work of Nicolia, A., A. Manzo, F. Veronesi, and D. Rosellini, entitled "An overview of the
last 10 years of genetically engineered crop safety research." The authors evaluated
1,783 scientific records of GE crop safety research papers, reviews, relevant opinions
and scientific reports from 2002-2012. Their findings concluded that "the scientific
research conducted so far has not detected any significant hazards directly connected
with the use of GE crops." In the article "Impacts of GM crops on biodiversity," in which
scientific findings concluded that "[o]verall, x x x currently commercialized GM crops
have reduced the impacts of agriculture on biodiversity, through enhanced adoption of
conservation tillage practices, reduction of insecticide use and use of more
environmentally benign herbicides and increasing yields to alleviate pressure to convert
additional land into agricultural use."
Debunking the supposed inherent risks and potential dangers of GMOs, petitioner
cites EUR 24473-A decade of EU-funded GMO research (2001-2010), concluded from
more than 130 research projects, covering a period of 25 years of research, and
involving more than 500 independent research groups, that "biotechnology, and in
particular GMOs, are not per se more risky than e.g. conventional plant breeding
technologies." Another article cited is "Assessment of the health impact of GM plant
diets in long-term and multigenerational animal feeding trials: A literature review"
which states that scientific findings show that GM crops do not suggest any health
hazard, and are nutritionally equivalent to their non-GM counterparts and can be safely
used in food and feed.
Further, the study is irrelevant and immaterial. The CrylAcc protein used in the study
was from engineered E. coli and may have been contaminated by endotoxin.
The CrylAcc used in the study was not from Bt talong. Hence, respondents' attempt to
extrapolate the interpretation and conclusion of this study to Bt talong is grossly
erroneous and calculated to mislead and deceive the Honorable Court.
Moreover, in a review by Bruce D. Hammond and Michael S. Koch of the said study by
L. Moreno-Fierros, et al., which was published in an article entitled A Review of the
Food Safety of Bt Crops, the authors reported that Adel-Patient, et al. tried and failed to
reproduce the results obtained by the study made by L. Moreno-Fierros, et al. The
reason is because of endotoxin contamination in the preparation of the CrylAc protein.
Further, when purified Cry protein was injected to mice through intra-gastric
administration, there was no impact on the immune response of the mice.
With respect to the interpretation made by Prof. Eric-Gilles Seralini, the same is not
entitled to any weight and consideration because his sworn statement was not admitted
in evidence by the Court of Appeals.
Further, Seralini's findings are seriously flawed. Food safety experts explained the
differences observed by Seralini's statistical analysis as examples of random biological
variation that occurs when many measurements are made on test animals, and which
have no biological significance. Hence, there are no food safety concerns. Further,
petitioner ISAAA presented in evidence the findings of regulatory bodies, particularly
the EFSA and the FSANZ, to controvert Seralini's findings. The EFSA and the FSANZ
rejected Seralini's findings because the same were based on questionable statistical
procedure employed in maize in 2007.
In addition, it must be pointed out that the Indian regulatory authority, GEAC,
has not revised its earlier decision approving the safety of Bt eggplant notwithstanding
the findings of Seralini's assessment. In effect, Seralini's findings and interpretation
were rejected by the Indian regulatory agency.
With respect to the interpretation made by Drs. Romeo Quijano and Wency Kiat, the
same is not entitled to any weight and consideration because the Court of Appeals did
not admit their sworn statement. Further, Drs. Romeo Quijano and Wency Kiat sought
to interpret a seriously flawed study, making their sworn statements equally flawed.
In an attempt to mislead the Honorable Court, respondents tried to pass off the review
of Prof. David A. Andow as the work of the National Academy of Sciences of the USA.
Such claim is grossly misleading. In truth, as Prof. David A. Andow indicated in the
preface, the report was produced upon the request of Aruna Rodriguez, a known anti-
GM campaigner.
Further, Prof. David A. Andow's review did not point to any negative impact to the
environment of Mahyco's Bt brinjal (Indian name for Bt talong) during the entire period
of conduct of field trials all over the country. He concluded, however, that the dossier is
inadequate for ERA. This is perplexing considering this is the same gene that has been
used in Bt cotton since 1996. Scores of environmental and food safety risk assessment
studies have been conducted and there is wealth of information and experience on its
safety. Various meta-analyses indicate that delaying the use of this already effective Bt
brinjal for managing this devastating pest only ensures the continued use of frequent
insecticide sprays with proven harm to human and animal health and the environment
and loss of potential income of resource-poor small farmers.
Notwithstanding the conclusions of Prof. David A. Andow, to date, it is worth repeating
that the Indian regulatory body, GEAC, has not revised its earlier decision approving
the safety of Bt eggplant based on the recommendation of two expert committees
which found the Mahyco regulatory dossier compliant to the ERA stipulated by the
Indian regulatory body. In effect, like Seralini, Andow's findings and interpretation were
also rejected by the Indian regulatory agency.35 ChanRoblesVirtualawlibrary
Petitioner reiterates that the PEIS law does not apply to field testing of Bt talong and
the rigid requirements under Section 8 of DAO 08-2002 already takes into consideration
any and all significant risks not only to the environment but also to human health. The
requirements under Sections 26 and 27 of the Local Government Code are also
inapplicable because the field testing is not among the six environmentally sensitive
activities mentioned therein; the public consultations and prior local government unit
(LGU) approval, were nevertheless complied with. Moreover, the field testing is an
exercise of academic freedom protected by the Constitution, the possibility of Bt
talong's commercialization in the future is but incidental to, and fruit of the experiment.
EMB, BPI and FPA joined in objecting to Annex "A" of respondents' consolidated
comment, for the same reasons given by ISAAA. They noted that the affidavit of Prof.
Seralini, and the joint affidavit of Dr. Kiat and Dr. Quijano were denied admission by
the CA. Given the failure of the respondents to present scientific evidence to prove the
claim of environmental and health damages, respondents are not entitled to the writ
of kalikasan.
Public petitioners reiterate that in issuing the Biosafety Permits to UPLB, they made
sure that the latter complied with all the requirements under DAO 08-2002, including
the conduct of risk assessment. The applications for field testing of Bt talong thus
underwent the following procedures:
Having completed the contained experiment on the Bt talong, UPLB filed with BPI
several applications for issuance of Biosafety Permits to conduct multi-locational field
testing of Bt talong. Even before the proponent submitted its application, petitioner BPI
conducted a consultative meeting with the proponent to enlighten the latter about the
requirements set out by DA AO No. 8.
Second. The applications were accompanied by a (i) Certification from the NCBP that
the regulated article has undergone satisfactory testing under contained conditions in
the Philippines, (ii) technical dossier consisting of scientific literature and other scientific
materials relied upon by the applicant showing that Bt talong will not pose any
significant risks to human health and the environment, and (iii) copy of the proposed
PIS for Field Testing as prescribed by Section 8 (A) (2) of DA AO No. 08; and
Third. The applications contained the Endorsement of proposal for field testing, duly
approved by the majority of all the members of the respective Institutional Biosafety
Committees (IBC), including at least one community representative, as required by
Section 8 (E) of DA AO No. 08.
a. Under Sections 1 (L) and 8 (D) of DA AO No. 08, the IBC is responsible for the initial
evaluation of the risk assessment and risk management strategies of the applicant for
field testing using the NCBP guidelines. The IBC shall determine if the data
obtained under contained conditions provide sufficient basis to authorize the
field testing of the regulated article. In making the determination, the IBC shall
ensure that field testing does not pose any significant risks to human health
and the environment. The IBC may, in its discretion, require the proponent to
perform additional experiments under contained conditions before acting on the field
testing proposal. The IBC shall either endorse the field testing proposal to the BPI or
reject it for failing the scientific risk assessment.
b. Relatedly, UPLB had previously complied with Section 1 (L) of DA AO No. 08 which
requires an applicant for field testing to establish an IBC in preparation for the field
testing of a regulated article and whose membership has been approved by the BPI.
Section 1 (L) of DA AO No. 08, requires that the IBC 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, and the other members are designated as "community
representatives" who are in a position to represent the interest of the communities
where the field testing is to be conducted.
Before approving the intended multi-locations [field] trials, petitioner BPI, pursuant to
Section 8 (F) of DA AO No. 08, forwarded the complete documents to three (3)
independent Scientific Technical Review Panel (STRP) members. Pending receipt of the
risk assessment reports of the three STRP members, petitioner BPI conducted its own
risk assessment.
Thereafter, on separate occasions, petitioner BPI received the final risk assessment
reports of the three STRP members recommending the grant of Biosafety Permits to
UPLB after a thorough risk assessment and evaluation of UPLB's application for field
trial of Bt talong.
Meanwhile, petitioner BPI received from UPLB proofs of posting of the PISs for Field
Testing in each concerned barangays and city/municipal halls of the localities having
jurisdiction over its proposed field trial sites.
Petitions-in-Intervention
Crop Life likewise assails the application of the Precautionary Principle by the CA which
erroneously equated field testing of Bt talong with Bt talong itself; failed to recognize
that in this case, there was no particular environmental damage identified, much less
proven; relied upon the article of Prof. Seralini that was retracted by the scientific
journal which published it; there is no scientific uncertainty on the adverse effects of
GMOs to environment and human health; and did not consider respondents' failure to
prove the insufficiency of the regulatory framework under DAO 08-2002.
On policy grounds, Crop Life argues that requiring all organisms/plants to be considered
absolutely safe before any field testing may be allowed, would result in permanently
placing the Philippines in the shadows of more developed nations (whose economies
rest on emerging markets importing products from them). It points out that the testing
of Bt talong specifically addresses defined problems such as the need to curb the
misuse of chemical pesticides.
II.
III.
IV.
Also reiterated were those grounds for dismissal already raised by the petitioners:
failure to exhaust administrative remedies and finality of findings of administrative
agencies.
On the "misapplication" by the CA of the precautionary principle, BCP explains that the
basic premise for its application is the existence of threat of harm or damage to the
environment, which must be backed by a reasonable scientific basis and not based on
mere hypothetical allegation, before the burden of proof is shifted to the public
respondents in a petition for writ of kalikasan. Here, the CA relied heavily on its
observation that "... field trials of bt talong could not be declared ... as safe to human
health and to ecology, with full scientific certainty, being an alteration of an otherwise
natural state of affairs in our ecology" and "introducing a genetically modified plant in
our intricate world of plants by humans certainly appears to be an ecologically
imbalancing act," among others. BCP finds that this pronouncement of the CA
constitutes an indictment not only against Bt talong but against all GMOs as well. The
appellate court's opinion is thus highly speculative, sweeping and laced with obvious
bias.
There being no credible showing in the record that the conduct of Bt talong field trials
entails real threats and that these threats pertain to serious and irreversible damage to
the environment, BCP maintains that the precautionary principle finds no application in
this case. While Rule 20 of the Rules of Procedure for Environmental Cases states that
"[w]hen 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 CA failed to note that the element of lack
of full scientific certainty pertains merely to the causal link between human activity and
environmental effect, and not the existence or risk of environmental effect.
BCP laments that sustaining the CA's line of reasoning would produce a chilling effect
against technological advancements, especially those in agriculture. Affirming the CA
decision thus sets a dangerous precedent where any and all human activity may be
enjoined based on unfounded fears of possible damage to health or the environment.
Issues
From the foregoing submissions, the Court is presented with the following issues for
resolution:
2. Mootness;
Legal Standing
However, the rule on standing is a matter of procedure which can be relaxed for non-
traditional plaintiffs like ordinary citizens, taxpayers, and legislators when the public
interest so requires, such as when the matter is of transcendental importance, of
overreaching significance to society, or of paramount public interest.40 The Court thus
had invariably adopted a liberal policy on standing to allow ordinary citizens and civic
organizations to prosecute actions before this Court questioning the constitutionality or
validity of laws, acts, rulings or orders of various government agencies or
instrumentalities.41
Oposa v. Factor an, Jr.42 signaled an even more liberalized policy on locus standi in
public suits. In said case, we recognized the "public right" of citizens to "a balanced and
healthful ecology which, for the first time in our nation's constitutional history, is
solemnly incorporated in the fundamental law." We held that such right need not be
written in the Constitution for it is assumed, like other civil and political rights
guaranteed in the Bill of Rights, to exist from the inception of mankind and it is an issue
of transcendental importance with intergenerational implications. Such right carries with
it the correlative duty to refrain from impairing the environment.
Since the Oposa ruling, ordinary citizens not only have legal standing to sue for the
enforcement of environmental rights, they can do so in representation of their own and
future generations. Thus:
Petitioners minors assert that they represent their generation as well as generations yet
unborn. We find no difficulty in ruling that they can, for themselves, for others of their
generation and for the succeeding generations, file a class suit. Their personality to
sue in behalf of the succeeding generations can only be based on the concept
of intergenerational responsibility insofar as the right to a balanced and
healthful ecology is concerned. Such a right, as hereinafter expounded, considers
the "rhythm and harmony of nature." Nature means the created world in its entirety.
Such rhythm and harmony indispensably include, inter alia, the judicious disposition,
utilization, management, renewal and conservation of the country's forest, mineral,
land, waters, fisheries, wildlife, off-shore areas and other natural resources to the end
that their exploration, development and utilization be equitably accessible to the
present as well as future generations. Needless to say, every generation has a
responsibility to the next to preserve that rhythm and harmony for the full enjoyment
of a balanced and healthful ecology. Put a little differently, the minors' assertion of their
right to a sound environment constitutes, at the same time, the performance of their
obligation to ensure the protection of that right for the generations to
come.43 (Emphasis supplied.)
The liberalized rule on standing is now enshrined in the Rules of Procedure for
Environmental Cases which allows the filing of a citizen suit in environmental
cases.44 The provision on citizen suits in the Rules "collapses the traditional rule on
personal and direct interest, on the principle that humans are stewards of nature," and
aims to "further encourage the protection of the environment."45
There is therefore no dispute on the standing of respondents to file before this Court
their petition for writ of kalikasan and writ of continuing mandamus.
Mootness
It is argued that this case has been mooted by the termination of all field trials on
August 10, 2012. In fact, the validity of all Biosafety permits issued to UPLB expired in
June 2012.
Nonetheless, courts will decide cases, otherwise moot and academic if: first, there is a
grave violation of the Constitution; second, the exceptional character of the situation
and the paramount public interest is involved; third, when the constitutional issue
raised requires formulation of controlling principles to guide the bench, the bar and the
public; and fourth, the case is capable of repetition yet evading review.48 We find that
the presence of the second and fourth exceptions justified the CA in not dismissing the
case despite the termination of Bt talong field trials.
While it may be that the project proponents of Bt talong have terminated the subject
field trials, it is not certain if they have actually completed the field trial stage for the
purpose of data gathering. At any rate, it is on record that the proponents expect to
proceed to the next phase of the project, the preparation for commercial propagation of
the Bt eggplants. Biosafety permits will still be issued by the BPI for Bt talong or other
GM crops. Hence, not only does this case fall under the "capable of repetition yet
evading review" exception to the mootness principle, the human and environmental
health hazards posed by the introduction of a genetically modified plant, a very popular
staple vegetable among Filipinos, is an issue of paramount public interest.
4. Receipt by BPI of new information that the field testing of the regulated
article poses significant risks to human health and the environment;
In addition to the TEPO and writ of kalikasan, respondents also sought the issuance of a
writ of continuing mandamus commanding the respondents to: (1) comply with the
requirement of environmental impact statement; (2) submit comprehensive risk
assessments, field test reports, regulatory compliance reports and other material
documents on Bt talong including issued certifications on public consultation with LGUs;
(3) work with other agencies to submit a draft amendment to biosafety regulations;
and (4) BPI, in coordination with relevant government agencies, conduct balanced
nationwide public information on the nature of Bt talong field trial, and a survey of its
social acceptability.
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.
Genetic Engineering
Genetic manipulation has long been practiced by conventional breeders of plant or
animal to fulfill specific purposes. The basic strategy employed is to use the sexual
mechanism to reorganize the genomes of two individuals in a new genetic matrix, and
select for individuals in the progeny with the desirable combination of the parental
characteristics. Hybridization is the conventional way of creating variation. In animals,
mating is effected by introducing the desired sperm donor to the female at the right
time. In plants, pollen grains from the desired source are deposited on the stigma of a
receptive female plant. Pollination or mating is followed by fertilization and
subsequently development into an embryo. The effect of this action is the
reorganization of the genomes of two parents into a new genetic matrix to create new
individuals expressing traits from both parents. The ease of crossing of mating varies
from one species to another. However, conventional breeding technologies are limited
by their long duration, need for sexual compatibility, low selection efficiency, and
restricted gene pool.51
Despite these promising innovations, there has been a great deal of controversy over
bioengineered foods. Some scientists believe genetic engineering dangerously tampers
with the most fundamental natural components of life; that genetic engineering is
scientifically unsound; and that when scientists transfer genes into a new organism, the
results could be unexpected and dangerous. But no long-term studies have been done
to determine what effects GMO foods might have on human health.54
The term GM food refers to crop plants created for human or animal consumption using
the latest molecular biology techniques. These plants are modified in the laboratory to
enhance desired traits such as increased resistance to herbicides or improved
nutritional content.55 Genetic modification of plants occurs in several stages:
2. The gene is then attached to a carrier in order to introduce the gene into
the cells of the plant to be modified. Mostly plasmid (piece of bacterial
DNA) acts as a carrier.
3. Along with the gene and carrier a 'promoter' is also added to ensure that
the gene works adequately when it is introduced into the plant.
4. The gene of interest together with carrier and promoter is then inserted
into bacterium, and is allowed to reproduce to create many copies of the
gene which are then transferred into the plant being modified.
5. The plants are examined to ensure that they have the desired physical
characteristic conferred by the new gene.
6. The genetically modified plants are bred with conventional plants of the
same variety to produce seed for further testing and possibly for future
commercial use. The entire process from the initial gene selection to
commercial production can take up to ten years or more.56
Benefits of GM Foods
Along with the much heralded benefits of GM crops to human health and environment,
there emerged controversial issues concerning GM foods.
In 1999, it was found that genetically engineered foods can have negative health
effects. Based on scientific studies, these foods can unleash new pathogens, contain
allergens and toxins, and increase the risk of cancer, herbicide exposure, and harm to
fetuses and infants.61 Independent studies conducted went as far to conclude that GM
food and feed are "inherently hazardous to health."62
A widely reported case is that of the Brazil nut gene expressed in soybean in order to
increase the methionine content for animal feed. The protein was subsequently shown
to be an allergen and the product was never marketed. Genetically modified foods can
introduce novel proteins into the food supply from organisms that are never consumed
as foods, which may pose a health risk. This may elicit potentially harmful
immunological responses, including allergic hypersensitivity.63
A feeding experiment conducted by Dr. Arpad Pusztai also demonstrated that potatoes
genetically altered to produce lectins, natural insecticides, to protect them against
aphids, damaged the animals' gut, other organs, and immune system. Dr. Pusztai found
that "the damage originated not from the transgene and its expressed product but from
the damage caused by the insertion of the transgene, probably due to insertional
mutagenesis."64 If confirmed, Pusztai's conclusions will reinforce concerns that gene
insertion itself may create new toxins; it will also implicate the toxin commonly used in
other genetically engineered crops - the Bt toxin which, Pusztai says, is also a lectin.65
The use of antibiotic resistance marker (arm) gene, inserted into a plant or microbe,
that helps determine if the foreign gene has successfully spliced into the host organism,
is another cause of grave concern among scientists. These arm genes might
unexpectedly recombine with disease-causing bacteria or microbes in the environment
or in the guts of animals or humans who eat GM food, thus contributing to the growing
public health danger of antibiotic-resistance of infections that cannot be cured with
traditional antibiotics (e.g., new strains of salmonella, e-coli, campylobacter and
enterococci).66 However, recent advances in genetic engineering indicate that use of
such selection markers is likely to diminish with the anticipated development of
alternative types of marker genes.67
Increased cancer risk is another critical issue in the consumption of GM foods. A growth
hormone genetically modified to stimulate milk production in cows was found to elevate
levels of IGF-1 (insulin-like Growth Factor-1, identical versions of which occurs in cows
and humans) in cow's milk by 80%. IGF-1 is reported to be a key factor in prostate
cancer, breast cancer and lung cancer.68 Dr. Samuel Epstein of the University of Illinois
warned of the danger of high levels of IGF-1 contained in milk cows injected with
synthetic bovine growth hormone (rBGH), which could be a potential risk factor for
breast and gastrointestinal cancers.69
Glyphosate, the active ingredient in Monsanto's Roundup® herbicide, has been found to
worsen modern diseases. A report published in the journal Entropy argues that
glyphosate residues, found in most commonly consumed foods in the Western diet
courtesy of genetically engineered sugar, corn, soy and wheat, "enhance the damaging
effects of other food-borne chemical residues and toxins in the environment to disrupt
normal body functions and induce disease." Another research demonstrated a
connection between increased use of Roundup with rising autism rates in the US.70
Genetically modified crops affect the environment in many ways such as contaminating
non-GMO plants, creating super weeds and super pests, harming non-target species,
changing soil microbial and biochemical properties, and threatening biodiversity.
There are two primary types of technology so far deployed: insect resistance (Bt) and
herbicide tolerance (HT). Both have drastic modes of action to kill the target species at
high efficiency. Bt crops contain a toxin lethal to certain insects, and Bt sprays have
been used by organic farmers as a last option to deal with certain pests like the corn
borer. It is feared that genetically modified Bt crops will speed up resistance to Bt,
thereby rendering the organic spray ineffective.71 Lab and field tests also indicate that
common plant pests such as cotton bollworms, living under constant pressure from GE
crops, will soon evolve into "superpests" completely immune to Bt sprays and other
environmentally sustainable biopesticides.72 In the case of HT, the technology involves
the combined use of a chemical herbicide and a GM plant. The herbicide is generally a
broad spectrum herbicide (commonly glyphosate or glufosinate) which kills weeds while
leaving the crop plant alive as it is genetically engineered to be resistant to the
herbicide. The herbicide acts to inhibit an essential enzyme that is found in all plants
and as a result is able to eliminate all weeds whereas most conventional herbicides are
selective in their action and target a limited number of weeds. Concern has been raised
regarding over-reliance on use of one or two herbicides in increased amounts over time
which leads to the emergence of herbicide resistant weeds. Also, the transfer of an
herbicide-resistance gene into a weed can convert it into a superweed. Pests and weeds
will emerge that are pesticide or herbicide resistant, which means that stronger, more
toxic chemicals will be needed to get rid of the pests.73
It is a well-accepted fact that genetically engineered plants can move beyond the field
sites and cross with wild relatives.74 It is by nature a design of plants to cross pollinate
to spread genes further afield. Maize, oil seed rape, sugar beet, barley, among others,
are wind and insect pollinated, allowing pollen to travel large distances. In GM crop
fields, pollen drift and insect pollination create obvious problems for nearby non-GM or
organic crops.75 GM maize could cross-pollinate neighboring non-GM or organic maize
crops. Maize pollen can travel at least 500-700 meters and still be viable and distances
of several kilometers have even been reported.76 But many experiments showed
varying results and actual cross-pollinations were observed in Mexico up to 200 meters
only, while in Oklahoma it was 500 meters. In crop species that are outcrossers, many
environmental factors influence the maximum pollination distance such as the size of
pollen grains, the humidity in the air, and the wind speed.77Brinjal is usually self-
pollinated, but the extent of cross-pollination has been reported as high as 48% and
hence it is classified as cross-pollinated crop. The cone-like formation of anthers favors
self-pollination; but since the stigma ultimately projects beyond the anthers, there is an
ample opportunity for cross-pollination. The rates of natural cross-pollination may vary
depending on genotype, location, and insect activity. The extent of outcrossing has
been reported from 3 to 7% in China and from 0 to 8.2% (with a mean of 2.7%) at
Asian Vegetable Research Development Centre; however the Indian researchers have
reported 2 to 48% outcrossing in brinjal varieties in India. Outcrossing primarily takes
place with the help of insects.78
The StarLink incident is also a widely reported GM fiasco. In June 2000, Starlink, a
genetically modified yellow corn which contains the pesticide Bt in every cell, was found
in white corn tortilla chips in Florida, USA. Starlink had been approved for animal feed
but not for human consumption due to concerns about dangerous allergic reactions.
The Starlink incident is often cited to illustrate how difficult it is to keep genetically
modified crops from spreading.79
This gene flow to wild species is particularly alarming to environmentalists. The wild
species from which our agricultural plants originate are an important genetic resource
for further plant breeding if, for example, there is a requirement for improved
resistance to climate change or plant pests. Future plant breeding could be jeopardized
if transgenes spread into these resources. Similarly, agriculture in the centers of origin
could be permanently damaged if transgenes spread into regional landraces.80 Invasive
species can replace a single species or a whole range of species, and they can also
change the conditions within ecological systems. Crossing can cause losses in the
genetic information of the original species, a reduction in genetic diversity and an
ongoing incremental change of genetic identity in the original plants. It is hard to
predict which species will become invasive.81 Indeed, GM crops could threaten the
centers of crop biodiversity or outgrow a local flora to the detriment of native species.82
In another review, it was stated that the direct effects of the plant that has been
modified is of the most concern since the introduction of transgenic proteins for pest
and disease resistance can involve the production of chemical substances that are
potentially toxic to non-target soil organisms, including mycorrhizal fungi and soil
microfauna that are involved in organic matter decomposition. Experimental studies
have shown that the transgenic proteins Bt crystal toxin and T4 lysozyme, though used
to prevent insect damage to the above ground plant parts, are not only present in root
exudates but that they maintain biological activity after entering the soil.85
As to the herbicide glyphosate, recent studies revealed its negative effects on the soil,
which include compaction and resultant runoff, the killing of beneficial microbes and
bacteria, and the exhaustion of necessary minerals and nutrients that plants require. It
was found that glyphosate "locks up" manganese and other minerals in the soil so that
they can't be utilized by the plants that need them, and that it is toxic to rhizobia, the
bacterium that fixes nitrogen in the soil. There is likewise evidence showing that
glyphosates can make their way to groundwater supplies.86 In a study which tested the
effects of the herbicide Roundup on six species of larval amphibians from North
America, it was demonstrated that when we "use realistic exposure times and the
frequently occurring stress of predators found in natural ecologic communities, one of
our most widely applied herbicides (Roundup) has the potential to kill many species of
amphibians." At the same time, the study noted that Monsanto Corporation has recently
released "an additional formulation of glyphosate (Roundup Biactive), which contains a
different (but unspecified) surfactant that is reported to be less toxic."87
Further, the parties presented their respective expert witnesses who testified on the
allegations raised in the petition concerning damage or threat of damage to human
health and the environment resulting from the conduct of Bt talong field trials in the
Philippines. The CA conducted "hot tubbing," the colloquial term for concurrent expert
evidence, a method used for giving evidence in civil cases in Australia. In a "hot tub"
hearing, the judge can hear all the experts discussing the same issue at the same time
to explain each of their points in a discussion with a professional colleague. The
objective is to achieve greater efficiency and expedition, by reduced emphasis on cross-
examination and increased emphasis on professional dialogue, and swifter identification
of the critical areas of disagreement between the experts.88
On November 20, 2012, the parties' expert witnesses testified in a hot tub hearing
before the chairman and members of the CA's Special Thirteenth Division. Dr.
Chakraborty, Dr. Medina and Dr. Malayang were presented by the petitioners while Dr.
Davies, Dr. Halos, Dr. Ebora and Dr. Cariño appeared for the respondents.
In his review of agricultural biotechnology around the world, he has not encountered
any verifiable report of a field trial of any GM crop that caused damage to the
environment and to human health. This involves more than 25,000 field trials in 20
years with crops such as Bt eggplant, Bt cotton, Bt corn, and others. The same applies
to the commercial cultivation of Bt crops, which have been grown in ever increasing
quantities worldwide for 16 years and now comprise the majority of the world acreage
of maize and cotton.
A recent European Union (EU) report which concludes that more than 130 EU research
projects covering a period of more than 25 years of research involving more than 500
independent research groups, show that consuming foods containing ingredients
derived from GM crops is no riskier than consuming the same foods containing
ingredients from conventional crops. The World Health Organization (WHO), American
Medical Association, US National Academy of Sciences, European Food Safety Authority
(EFSA) all have come to the same conclusion.
GMOs have been proven safe as conventionally-bred crops in animal studies. A small
number of poorly done studies purportedly claiming negative effects, should be viewed
with great caution and have been highly criticized for their veracity by the
overwhelming majority of highly respected scientists. Many hundreds of studies show
no harmful effects. To date, not a single rigorous study of GM foods in animals has
revealed any adverse effect; not a single case of allergy, illness, cancer, or death have
been shown to be associated with foods derived from GM crops, despite the fact that
they have been consumed by Americans for 16 years.
Recent studies indicate that Bt crops enhance the ecological diversity in the areas
surrounding those where Bt crops are grown. Over a period of 13 years, cultivation
of Bt cotton in China results in an increase in insect diversity and abundance and a
decrease in crop damaging insects not only in Bt crop fields but also in surrounding
non-Bt fields.
DR. HALOS, Ph.D. in Genetics, University of California Berkeley, B.S. Agriculture, Major
in Agronomy (Plant Breeding), UPLB, and served as Instructor, Associate Professor,
Chief Science Research Specialist, Research Director at UPLB, UP Diliman, De La Salle
University, Forest Research Institute now Ecosystems Research and Development
Bureau of DENR and the Biotechnology Coalition of the Philippines.
Since 2002, BPI has granted 95 biosafety permits for field trials. Of these 70 field trial
permits were for Bt corn, cotton and eggplant. No adverse effect of any of these Bt crop
field trials have been reported. No report of adverse effects of Bt crop field trial exists.
All claims of adverse health and environmental effects of Bt crops has not been
scientifically validated. The yearly expansion of GM crop areas in both the developing
and industrialized countries is an attestation of the preference of farmers and the
economic benefits that accrue to them.
DR. EBORA, Ph.D. in Entomology, Michigan State University; B.S. Agriculture and M.S.
Entomology (Insect Pathology/Microbial Control), UPLB; Post-graduate trainings in
microbiology and biotechnology, Osaka University, Japan, and Intellectual Property
Management and Technology Transfer, ISAAA AmeriCenter, Cornell University, USA.
Director, and Research Associate Professor, National Institute of Molecular Biology and
Biotechnology (BIOTECH), UPLB; Philippine Coordinator of the Program for Biosafety
Systems; former Executive Director, Philippine Council for Industry, Energy and
Emerging Technology Research and Development, DOST; former Chair, Biosafety
Committee, DOST; and was a Member of the Institutional Biosafety Committees of
UPLB and International Rice Research Institute (IRRI); and was extensively involved in
the isolation, bioassay or efficacy testing and development of Bt as microbial
insecticides for the control of Asian corn borer and mosquito larvae at BIOTECH.
The contained field trial experiments, among others, were designed to address concerns
on cross-pollination or horizontal gene transfer, pollination distances, harm to beneficial
organisms, and development of insect resistance. To prevent cross-pollination, an
isolation distance of 200 meters from other areas where eggplants are grown or wild
relatives are present, was observed, and with five (5) rows of non-transgenic eggplants
that serve as pollen trap plants. As to the flight distance of honeybees reaching 4
kilometers, what was not mentioned is the viability of pollen after it was shed and
travelled at a certain distance. Numerous literatures have shown that isolation
distances much less than 200 meters is sufficient to prevent cross-pollination. Two
studies are cited: Sekara and Bieniasz (2008) noted that cross-pollination at a distance
of 50 meters was nonexistent; and the Asian Vegetable Research and Development
Center (AVRDC) indicated that eggplants produce perfect flowers which may be cross-
pollinated but self-pollination is more common, the extent of natural crossing depends
upon insect activity and this can be avoided by isolating each variety by 20 meters or
with another tall flowering plant. The isolation distance imposed by DA-BPI is 1 Ox the
recommended isolation distance; the 200 meters distance was found sufficient for pure
seed production in India (the same recommendation by Chen [2001] of AVRDC
foundation for seed production purity standards); field studies in 2 locations in India
have shown that at a distance beyond 30 meters no more outcrossing could be
detected. Taking all these data into account, the 48% outcrossing being raised by
petitioners is most likely for adjacent plants and therefore not a valid argument for the
on-going field trials.
The Bt talong will not directly affect beneficial organisms like pollinators, predators and
parasites of insect pests because it is toxic only to caterpillars or insects belonging to
Order Lepidoptera (butterfly and moths). The selective toxicity of Bt protein in Bt
talong is partly due to the fact that the gut physiology of these insects is very different
from caterpillars, and not all caterpillars are affected by it. There is a significant number
of literature on Bt protein's selectivity and specificity.
As to the development of insect resistance, this is not possible during the multi-location
field trials for Bt talong because of low selection pressure and limited exposure of the
insect pest to Bt talong. Insect resistance is not unique to GM crops as it is a commonly
observed biological reaction of insect pests to control measures like insecticides. In the
event Bt talong is approved for commercialization and will be widely used by fanners,
this concern could be addressed by insect resistance management (IRM); an IRM
strategy should be required prior to the commercial release of Bt talong.
There is no compelling reason to stop the field trials; on the contrary they should be
allowed to proceed so that scientists and researchers will be able to generate valuable
data and information which will be helpful in making informed decisions regarding the
usefulness of the technology.91
For Respondents
He is concerned with how GMOs are being introduced for commercial-scale use (as
against being used for academic research) in the Philippines on the following grounds:
(a) how they might contaminate the indigenous genetic resources of the country; (b)
how they may cause an imbalance of predator-prey relationships in ecosystems, so that
certain species might dominate ecological niches and erode their biodiversity and
ecological stability; (c) how they may erode the ability of farmers to control their
genetic resources to sustain their cropping systems; and (d) how much are present
biosafety protocols able to safeguard the long-term ecological and economic interests of
the Philippines as a particularly biodiversity-rich country and which is, therefore, highly
sensitive to genetic pollution; to the extent that its biodiversity is its long-term equity
to advances in biotechnology, the most robust measures must be taken so that such
resources will not be lost.
Being a highly biodiversity-rich country, biosafety measures in the Philippines must be
adopted using a 3-stage approach: Stage 1 - Develop criteria for biosafety measures;
meaning, first, adopt a set of standards for determining the level of robustness of
biosafety measures and protocols that would be acceptable in the particular case of the
Philippines; include required scoping and internal and external validity requirements of
impact and safety assessments; Stage 2 - Using the criteria produced in Stage 1,
develop biosafety measures and protocols to be adopted in the Philippines; and Stage 3
- Apply the protocol with the highest rigor.
Biosafety must be a public affair involving a broad spectrum of the Filipino state rather
than its considerations being restricted only to specific professionals and sectors in the
country; biosafety must be based on an enactment of Congress and open to challenge
and adjudication against international laws; provisions must be made to make it a
crime against humanity to recklessly erode and weaken genetic resources of our
people.92
Based on her studies and extensive experience, the Bt talong field testing poses the
following risks or hazards: (a) While natural Bt sprays used in organic farming have
little effect on non-target organisms because the bacterial 'pro-toxin' is in an inactive
state and only becomes toxic when processed and reduced in the gut of certain
(targeted) species of insect larvae, in contrast, Bt plants contain an artificial,
truncated Bt gene and less processing is required to generate the toxin because the
toxin is already in its active form. It is therefore less selective, and may harm non-
target insects that do not have the enzymes to process the pro-toxin, as well as the
pests for which it is intended; (b) Bt proteins from natural Bt sprays degrade relatively
quickly in the field as a result of ultraviolet light and lose most toxic activity within
several days to two weeks after application. In Bt crops, however, the Bt toxin is
produced by the internal system of the plants thus non-degradable by mere exposure
to sunlight and generated throughout the entire lifespan of the plant; (c) Bt talong can
also affect the environment by harming important or beneficial insects directly or
indirectly. Genetically engineered Bt eggplant, like other Bt crops, could be harmful to
non-target organisms if they consume the toxin directly in pollen or plant debris. This
could cause harm to ecosystems by reducing the numbers of important species, or
reducing the numbers of beneficial organisms that would naturally help control the pest
species; (c) The evolution of resistance to Bt crops is a real risk and is treated as such
in ecological science throughout the world. If enough individuals become resistant then
the pest control fails; the pest becomes abundant and affects crop yield. Granting the
pest control practice is successful, it may also simply swap one pest for another, a
phenomenon known as secondary pest outbreak. Several studies have shown that other
pest insects are filling the void left by the absence of the one (or very few) insect pests
that Bt crops target, and this is now the problem with Bt maize.
Eggplant is 48% insect pollinated thereby any field release or field testing of genetically
modified Bt talong will eventually lead to contamination of non-genetically modified
eggplant varieties. Insects, particularly honeybees, can fly as far as 4 kilometers and
therefore the 200 meters perimeter pollen trap area in the confined field testing set by
BPI is not sufficient. And once contamination occurs, genetic cleanup of eggplant or any
other plant is impossible. Moreover, intra-specific gene flow from Bt talong to other
varieties and populations of eggplants should be examined, as cultivated eggplant
(Solanum melongena) can cross breed with feral populations of S. melongena, and it is
possible that cultivated varieties can revert to wild phenotypes. Additionally, there is
likely to be natural crossing between Bt talong and wild relatives. Hybridization with
perhaps as many as 29 wild relative species needs to be evaluated carefully and the
consequences of any hybridization that occurs needs to be evaluated.
In 2010, the Minister of Environment and Forests of the Government of India, in his
decision for moratorium of Bt Brinjal, listed potential contamination of eggplant
varieties as one of the reasons why the release of Bt Brinjal was not allowed. Dr. Andow
of the University of Minnesota also published an 84-pages report on the Environmental
Risk Assessment of Bt Brinjal, and among his conclusions is that several environmental
risks were not considered and nearly all the risk assessment done were inadequate. He
concluded that until the risks were understood or managed, there seems to be little
reason to approve Bt Brinjal release.93
Even the short term benefits of GM agriculture are not scale neutral, or location-
independent. It will help the monopoly agribusiness and the expenses of monopolistic
competition or cooperative organic farming. Hot climate and rich biodiversity is
detrimental towards the effectiveness of Bt constructs, and helpful towards unintended
gene flow. Moreover, the genetic manipulation is no way fail safe or exact. Shotgun
techniques are being adapted, aided by focused laboratory based screen of traits -
rather than the host or the full natural product. The GM labeling is avoided to cover up
this major fault.
The tendency to avoid the available risk assessment, and test is very clear in the GM
agribusiness. Before going ahead with spread of this technology, even in a batter form,
the foremost task is to establish rigorous test and assessment procedures. There are
excellent available tools of preteomics, transcriptomics, and metabolomics for detailed
compositional analysis in our hand to do this. Please ask, why they are not being
employed? In fact, there is not a single centre to test GM products on behalf of the
corporate GM Agribusiness house. Thus, low level, long term toxicity of GM foods are
yet to be tested. I believe the time has come to establish a standardization facility to
carry out such test facility in any country before giving permission to GM trial or
cultivation.94 ChanRoblesVirtualawlibrary
The relevant portions of the "hot-tub" hearing held on November 20, 2012, are herein
reproduced:
Dr. Cariño: chanRoblesvirtualLawlibrary
Chairperson: chanRoblesvirtualLawlibrary
So, actually, there is no full scientific certainty that it does not cause any harm
pertaining to health?
BT Talong per se, has hot been fully evaluated yet that is why it is undergoing trials. If
reporting of the BT toxin in BT Talong is CrylAcc, there are numerous studies that had
been actually published on relative safety of CrylAcc protein and it is actually
considered as an additional protein and the various reviews can be seen in the OECD
Digest of risk assessments on CrylAcc protein. Alternatively, if you are looking at the
possibility of harm coming from the introduced protein as yet, we have not done a full
blown assessment of it as of the moment. But we look at the protein sequence and with
a comparison of its sequence with other sequences in the data basis to see if it is
similar to this amino acid sequence of other known toxins and, so far, I have actually ...
in my affidavit, I have actually seen personally that it is not closely related to any of
the known toxins that are found into its system.
Chairperson: chanRoblesvirtualLawlibrary
So, in effect, we can not really say that BT Talong is perfectly safe for human
consumption?
Chairperson: chanRoblesvirtualLawlibrary
No, it has not been eaten, as far as I know. Even in India it has not been consumed by
human beings because it has not been introduced as a commodity.
Chairperson: chanRoblesvirtualLawlibrary
But what is the ultimate purpose of growing BT Talong? It is not for human
consumption, of course?
If it passes the safety assessments. That there is always a peak condition that, if it
would not to be evaluated in a step of the way much like to evaluate any new product
that is coming into the market evaluation, goes on a step-by-step and at least day-to-
day basis.
Your Honor, may I interject, may I suggest with your permission? I would just like to
make a little bit of explanation.
Chairperson: chanRoblesvirtualLawlibrary
Proceed.
I would like to address "BT" as a compound which is distinct from a plain in "Talong".
First of all, I think of the name BT toxin is very fortunate. It is really a protein. A
protein is an essential constituent of life. It is an essential constituent of our food. In
the human body, and in the body of other animals, this protein is under the same as
any other protein in food. It has no effect on the human body. This has been shown for
many, many years, knowing BT Talong but BT has been a constituent of "maize" in
commercial production for 16 years.
xxxx
x x x So it has been in corn for 16 years after substantial trials. It has been consumed
by Americans in corn products and by any other people who in[g]est American maize
corn products x x x. There is not a single case of illness or toxicity or allergenicity that
can be or that has been associated with this protein and, therefore, any food containing
this protein has been declared by authorities in all the countries that was mentioned by
my colleagues, including the European Union and the United States x x x to be as safe
as any food derived from the same plant species not containing this gene. I hope that
explains a little bit about what it is.
Chairperson: chanRoblesvirtualLawlibrary
Are you aware of a study, Dr. Davies, released on September 20 of this year, saying
that Monsanto's genetically modified corn is linked to cancer?
Yes. Are you referring, your Honor, to a publication by a French Scientist named Gilles-
Eric Seralini? I think this is one of the publications by Seralini's group. Dr. Seralini's
work has been refuted by International committees of scientists...
xxxx
Your Honor, may I butt in? It is wrong that proteins can not be toxins. Think about the
snake venoms. They are poisons, so whether it is protein or not that is not the
question. So proteins obviously venoms and proteins and enzymes and they are
poisons so protein can be a poison so that is now the point at all to be considered. The
second thing is, yeah, low level toxins long term in[g]estion of this BT toxin in human
or in any other animal have not been tested. So that is true so we do not know direct
consumption of this, because notice have been turned down, that is the objective fact.
The third point is about the "American Corn", and if I can give you such anecdotes,
"American GM Corn" are not labelled, how do you know that? What is its effect? What is
its toxicity? And, obviously, there are more than a hundred of papers showing and
published in very good journals. I can give many references which have shown the
detrimental effect of BT Toxin.
xxxx
Chairperson: chanRoblesvirtualLawlibrary
But before having this BT talong scheduled and allowed for field testing, is it not proper
that it should be first determined whether this food product is really safe for eating or
not?
There is an initial assessment that is generally done and according to the Codex
Alimentarius of the WHO, the thing that you do at this early stage of development is to
compare the sequence of the protein that is being introduced with published sequence
of allergens, as well as toxicants and toxins. So that has been done. Then you have to
look for instability under heat conditions because there is seldom do we heat grow
eggplants, so is it stable under heating. Is it stable in the presence of digestive juices?
And, if the answer is "yes", there is at least fair certainty, a fair assurance that it is
likely to be safe but then you start thinking of what other component not present in the
product, does this. For example, any product that we consume today has something
that is bad for you, otherwise, you will not see it right now. Otherwise all the different
herbivores will be eating it up, right? It will be extinct if it does not have anything to
protect itself and, so, the thing is one, to quantify how much of that has changed when
you lead the genetic modification. So "Talong" has been known to have Solanine and
glycoalkaloids whose level well have to quantify. We have not done that yet. They have
not submitted the data for that and this as secondary metabolize whose relative
concentration will change depending on the environment to which you actually place
the system.
xxxx
Justice Antonio-Valenzuela: chanRoblesvirtualLawlibrary
And, I was wondering in the conduct of the tests, the field testing x x x what would be
the effect of the planting .... of the existence of the genetically modified organism, for
example, on insects, on the soil, on the air? And then I was thinking, does this have
this particular protein that result[s] due to the genetic modification? Is it ... how is it
expelled, for example how does it go into the environment? Or, on the other hand, how
does it go inside and out of human system so that does it disintegrate or is it just there
forever? I am very curious, sir. You have to educate me.
x x x Okay, the DNA is in every cell of the eggplant and, so, a very small amount to
protein produced by each cell will be this BT protein. It does not get into the
environment in general. A very small amount might be in the pollen or in the leaves
that fall to the ground but it has been shown to be broken down in the soil by
organisms so it will not exist in the environment. The only way that it is going to get
into animals or insects is if they eat the fruit and this is what an insect that the "talong"
fruit and shoot borer will be trying to. But, if it eats it, it reacts with its intestine so that
they become toxic to the caterpillar but this is very specific to the digestive system of
the caterpillar. It does not affect bees. It does not affect animals. It does not affect
humans.
xxxx
At the scientific level, it gets changed by alkalinity of the insect gut and reacts with
specific receptors of the cells of the walls of the insect gut. But, this is very specific to
the gut of these insects namely the "Lepidoptera" and some "coleoptera" which are the
butterflies and the beetles but it will only affect if they try to eat the plant. Now, you
are asking us if what is the effect on the environment. x x x I would like to cite x x x a
recent paper published in the journal "Nature" x x x the most prestigious scientific
journal in the world, x x x published in "Nature" in June this year and this is the result
of a study of "insects" in BT Cotton fields in China in 17 locations for 14 years of a long
period study. And these scientists revolt that they show a marked increase in the
abundance of three types of generalist arthropod predators (ladywings, lacewings and
spiders) and a decrease in abundance of aphid pests associated with widespread
adoption of Bt cotton. And they are referring to China and they conclude that such
crops, x x x BT crops, can promote beneficial control services in agricultural landscapes.
And, it also showed that these effects extend beyond the field. So, essentially x x x
they found that there were more insects than in conventionally grown cotton and the
insect diversity was greater surrounded than being detrimental to an agriculture
ecosystem such BT cotton falls beneficial.
May I interject, your Honor. Now he is citing one paper they are. But in "Nature," there
was another news article, "Battlefield". One stream ecologist in United States itself, in a
university, she has studied the effect of growing BT Corn in the field and what is the
effect on the stream ecology, the west water, what is happening to other insects,
insects in which it is getting that BT toxin will not go. Yes, she has found that stream
ecology...
xxxx
Why was it published in "Nature" when that stream ecologist from Loyola University
Chicago in Illinois published that paper, published that article in PNAS or Proceedings of
the National Academy of Sciences, a prestigious journal? Now, they have to desert her.
She was abused, so her file was taken out. So people started e-mailing, threatening
her. So "Nature" has to publish that. How dirty the field has become so they entitled it
"Battelfield." If anybody produces any evidence that BT Toxin or GM Technology is
doing any harm to the environment then it will be battered by the entire English lobby
so there is worst the situation. But National Academy of Sciences in United States has
taken a strong decision and, in last year, there were six publications that published
where strong evidences are being produced about the environmental and ecological
damage cause[d] by this technology. So, that is the case.
Chairperson: chanRoblesvirtualLawlibrary
Second example, the Union Carbide Plant in Bhopal, India. It was among the most
advanced production ton at its time, yet, we know what happened. x x x Union
Carbide's [hurry] to set up a plant to take advantage of a large pesticide market in
India to help the country's farmers led to a massive and deadly safety failure.
The Third example is the green revolution, x x x involves, however, the wide [use] of
synthetic chemicals for fertilizer and pesticides that were [at] the time hailed as wonder
technologies. Many scientists in the world at that time argued for their wider use but
they later turned out to harm people, soils and water. They prove good then bad, so
bad that scientists today are using their ill effects as justification for adopting
alternative technologies to get us out of the synthetic chemical regime in agriculture.
And finally, the most common example would be the unintended effects of medicine. x
x x Medicines are technologies intended to do good but, with even the best science and
the vetting processes using rigid safety and risk assessment methods, they still could
cause side effects entirely undesired and many of which can cause chronic or acute
threats to human life. This includes the use of "DDT" that was used to control lice
among soldiers after the II World War which, after all, proved to be very bad.
x x x another thing I would like to point out to the Court is, if you come into a market
in the Philippines and you see nice Talong, it has probably been treated with various
insecticides. So, there has been insecticide spray on your tips in your crops which are
going to be harm on your farmers, your farmer's children, the insect populations and
also dangerous to the consumers as well. By contrast, Bt Talong, if it is adopted,
the BT has been shown to be beneficial to the insects and the environment and also has
been shown not to be toxic in food. Therefore, we are changing a highly toxic chemical
application for a much more benign modern technique that is beneficial to the
environment and beneficial to the consumers. That is my comment with the views just
made by my Filipino colleagues, your Honors.
x x x You know, in ecology and, I am sure you are aware of this, an expansion of
anyone population or a reduction of that population it would still be both not beneficial
to the healthful and balanced ecological health of the ecosystem. So to say that
because the population of insects are exploded and the diversity of insects exploded as
a result of this particular intervention is not necessarily good. That is my first point. The
second one, you mentioned x x x the "talong" is laden with pesticide. The same
pesticide were advised by scientists from the USAID before for us to use in this country
because this is how to expand our production of food. This was part of the green
revolution, the systemic use of pesticides and fertilizer. Now, of course, they were
misused, I can guarantee that but, again, if that be the case, in the case of pesticide
why can it not be in the case of BT that it can also be misused? x x x we are talking
here not of the science or of the technology but on the policy aspect of the adoption of
the technology. As I said, I am talking about the bakery not of a baked-bread.
Well, the use of pesticide in the eggplant, right now, is very much abused. x x x In
terms of the use of Bt Talong, then, that kind of misuse is not going to happen x x x.
Now, in the Philippines, we have a very strict highly monitored field testing and I think
Dr. Malayang knows about that because he was one of those who prepared the
guidelines for the field testing. So that is not going to happen, it is a very strict
regulatory system. We are known for that, actually, and...
xxxx
No, no. It does not happen because we have a risk management plan x x x.
xxxx
And why is this, ma'am, why are we monitoring? Because they could be harmful?
Yes, why? Because if you are sure that they are safe, if you are sure that they are safe,
why monitor?
Well, we are going to give you the data for that because you keep on asking, you know,
you asked for a long term and we are going to give you that complete data.
xxxx
I would like to raise several issues because I feel they are misleading sometimes. Dr.
Davies mentioned that the BT protein is a protein, therefore, it is safe. Are you sure
that all proteins are safe, Dr. Davies? Are you aware of anti-nutrients and allergens and
other kinds of protein x x x it is a misleading generalization. Secondly, I would like to
say also that, when you say that BT crops is beneficial to insect population but, how
about humans? But, let me tell and inform the Honorable Justices also that, in
agriculture, there can be, the pests are there to reduce the yield. There are also
diseases so, that this Bt is only controlling one kind of pest and, in my monitoring of BT
corn as an example to this 2 years after the commercialization in 2003, at first planting
in 2003, the corn is attacked by about a dozen insect pests and six major diseases.
The Bt corn was attacked a "stem rot", a fungal disease. And, in this case in eggplant,
there are many fungal diseases, "phomopsis" x x x So in that case it is not field safe
that you will not be using pesticide anymore with BT eggplant. When you use
the BT eggplant, assuming that there is no more insect pests x x x There are many
other methods of control and, therefore, do not assume that you do not use pesticide
therefore, BT is the only solution. That is also a risky and wrong generalization or
statement, x x x Dr. Halos x x x says that field tests are safe. I intend to disagree with
that. Safe to what? Especially to contamination. If I may use this picture of the field
testing of the Bt eggplant x x x it was encircled with cyclone wire with a diameter of
something like approximately 10 cm. by 7 cm. hole. While bees that can pollinate that,
the size is about 1 cm. in length and .5 cm. in diameter of the insect. The bees and, in
that case, they can easily get in and get out and when they settle into the flowers and
snip nectars and the fall of the pollen then they can bring out the pollen to contaminate
outside that. In fact, even assuming that the fence is very small in size of the mess, the
holes, still the insects can fly above that fence because the fence is only about 5 feet in
height. So, in that case it is not safe. Some arguments say that "well the pollen will be
dead" but, according to this technical manual of the Training Workshop On Data
Collection for Researchers And Collaborators of Multi-Location Trials of Fruit and Shoot
Borers Resistant Eggplant, that is the Bt Eggplant produced by the Institute of Plant
Breeding in UPLB who is one of the main researchers the datas, here say according to
"Rasco", cited by Dr. Narciso, is that the pollen can live 8 to 10 days pollen by ability at
20 to 22 degrees centigrade, with a relative humidity of 50 to 55. x x x Meaning to say,
that pollen can survive. This can fly as fast as something like 60 kilometers per hours
so it just take may be 3 minutes and it can travel 4 kilometers and 4 kilometers is the
effective flying distance of a bee in their normal foraging.
xxxx
x x x There is no data on the contamination so how come they argue, how can they
conclude that it is safe when they have not monitored any potential pollen flow by
insect mitigated or insect mediated flow pollen? So, in that case, the conclusion or the
statement is really beyond what their data may be is if their data is about safety.
xxxx
xxxx
x x x I hope that we will be able to look at the experimental design and you will see
that all the things are properly addressed, our risk assessment was done step by step,
x x x I beg to disagree with my friend Dr. Medina because it is becoming ... we are
confusing 2 things. We are not referring to contained trial. We are referring to confined
field trial and in the design of this particular experiment, you have your BT eggplant,
your non-BT eggplant so that you can compare the performance with the 2 crops. And,
on design, you have 5 rows of plant BT eggplants that will serve as a pollen trap. When
we say pollen trap is that it just open the pollen from the transgenic. It is going to be
trapped by those plants, 5 rows, and then, after that, you have a space of 200 meters
surrounding the field which is the isolation distance. That means no eggplant should be
present in that particular distance because that is the isolation distance that is found to
be safe, x x x we know that Bt protein is very specific x x x effective only against
caterpillar x x x if they are eaten by other organism, they are not affected because it is
very specific. The gut of the larva is very alkaline while the gut of other insects is likely
acidic and, in that case, it does not have any harmful effect, x x x So another thing is
we are saying that it seems to be ridiculous that you are saying that honeybee is going
to fly from the fence and the size were even indicated. I would like to indicate that, that
is not the purpose of the fence. It is not to contain the insects. It is to prevent
vandalism which is quite, unfortunately, being done by other groups who are against
the technology. x x x We should be able to have our own space, our own time,
considering the given regulation. Follow them. But our experimentation not be
destroyed because it is only then that we will be able to get the valuable data that is
needed for an informed decision. Without that we will not be able to proceed and I hope
we can discuss this based on the merits of the field trial, not from any other concern
because the writ of kalikasan is about the effect of field trial in the environment.
Mr. Justice, can I give this immediate counteract to the one statement of Dr. [Ebora]?
He said that the "CrylAcc" is specific to caterpillars and, in fact, only some kinds of
caterpillar, some species, if you can read by chemical and by physical research
communications this is Volume 271, pages 54-58, authored by Vasquez Pardonnet,
published in 2000, publication under letter (b), "CrylAcc protoxin" binds to the mucosal
surface of the mouse small intestine. Small intestine ay mammal po iyan so, meaning,
it is a proxy animal for safety [testing] to humans because we are also mammals so,
the mice are usually the mammals 12 years ago, the data has been already there that
there is binding site, therefore it is not only specific to insects but also to mammals. x x
x he is saying that, by working on the natural BT is the same as the transformed BT it
is not true because the natural BT has 1155 "base pairs" of nucleic acids. And the
transformed GM Crop contains a fragment of that BT gene which is only half of that.
And the mechanism, by the way, x x x the natural toxin is broken into smaller pieces
inside the intestine of the insects because it is alkaline in terms of its system "ph" and
for humans acidic. So it does not work. But, because the transformed BT is already
half, almost half of the normal or natural[ly] occurring BT protein, it is already
activated and, in that case, that is the reason why there is a test and immediate effect
to non-insect, meaning, to mammal, so that is the explanation of scientist doing studies
on that aspect.
x x xx
The scientists have 3 problems: One, the sparks, we have a tunnel vision; the second,
fear vision; x x x I will give some example. Yes, BT toxin, was it really good biological
control agent? But it is a completely different gene when you produce it into an edible
plant inside genetically. So, these are 2 different things. What will happen? We are
scared that the efficacy, the use of BT toxin as a spray, as biological control agent, will
be vanished because now there will be resistance against those in BT toxin, x x x
resistance is coming very quickly, just like antibiotic resistance, x x x The second thing,
I have asked many plant biologists this simple question, simple honest question. Do
you know any plant that can kill a bee or a moth? No! There is no way, why? Because
those are the "pollinators". Plant never kills a bee or a moth that goes against nature, x
x x So, nature, for thousands of years, farmers help select or adopt edible non-toxic
plants. And, now, with the high science we are converting them, non-toxic edible plant
into a toxic plant. So not only toxic for the human, for the root microorganisms, x x x
Those eggplants are not only for humans to consume. So human effect, we do not
know but what will be the effect? Who will mind the effect? Is it the animal which goes
through it? x x x in India, x x x farmers x x x while growing BT cotton x x x the leaves
and other they use to attract animals to eat. x x x they found suddenly one thing that
the BT cotton plants are not touched by those buffalos, those cows, those [boars], but
they can distinguish which is BT and non-BT. x x x and when their animals started
dying in some cases, they always blame, it is this animal which has eaten that BT? x x
x these are [going] against nature. Only few edible seed plants are there and we are
converting one safest plant into a poisonous and toxic plant and what is the effect on
the root microorganisms on the degrading animals and other? We do not know. That
hard thing is the tunnel vision, the confined field trial, x x x why implement this
confined field trial? Is this safe? Why do they have to do this x x x these things do good
for a normal hybrid that is something but for the gene concept we cannot follow the
same separation rules, same rules? So those are used, those separation distincts, those
parameters are used not for the gene. So, which is the safe field trial protocol for the
gene plants? We do not know. So there goes against [the] writ of kalikasan.
xxxx
x x x The average increase yield is about 24% and that is for corn. And this data is
actually taken by our own Filipino scientists, Dr. Lluroge and Dr. Gonzales.
xxxx
x x x my question is for Ma'am Nina. I have not been up to date lately on the
production of corn so, you mean to say that corn production in the country has gone up
and, because of that, you are saying that 24% and the income of farmers had gone up
as well? Do you mean to say that the price of com had also gone up as a result of the
increase in the volume of com production in the Philippines?
Dr.Malayang: chanRoblesvirtualLawlibrary
Yes.
xxxx
x x x there are a lot of local studies being conducted now by entomologists from [UPLB]
and those are independent studies. And, precisely, this is to determine the effect on
natural enemies and the different insects x x x and some of those are already available,
x x x you will be able to protect the environment only if you know how to have a proper
information in making the decision. So, again, I am saying that, in field trial, you will be
generating a lot of information that you will be able to use in making a wise decision
and informed decision.
x x x I would like to correct the impression lodged by the statement of Dr. Chakraborty
regarding butterflies and moths. Because they are not affected by BT because they are
adult insects. The only one that is affected are actually the larva, not even the pupa.
So, we would like that to be clear because it might create confusion.
The other thing in resistance, x x x even conventionally bred plant [loses] resistance
after sometime and that is the reason why we have a continuous breeding program. So,
it is a natural mechanism by an organism as mode of ad[a]potation. x x x are you
telling us that we are going to stop our breeding work because, anyway, they are going
to develop resistance. I think it is a wrong message x x x.
The other thing is in terms of the study cited by Dr. Medina regarding the "binding." In
toxicology, you can have the effect if you have, for example, the insects, you have a
receptor. The toxin will bind into the receptor. Toxin has to fall and then the toxin has
re-insert into the membrane. If you eliminate one of those steps you do not have any
toxicity. So, that means binding by itself will not be toxicity. It is a wrong impression
that, since you have binding, there will be toxicity. It is simply wrong because, the
actuality that it should bind, it should fall then, it should insert, and it is a very common
x x x. To say that binding is equivalent to toxicity is simply not true.
The other one is natural BT toxin and activated toxin. When you were saying protoxin,
protoxin is basically the entire crystal protein. If it is already inside the gut of the insect
it has to be clipped by the purchase coming from the gut and you have it activated and
you have the toxin. So what you have in plant is already the toxin since the anther and
the toxin, and the toxin in microorganisms, the anther which are already clipped by a
purchase are the same. So, to say that they are different is actually wrong. You are
comparing protoxin and toxin.
xxxx
x x x the field trial wanted to basically go to the protocol. This is the efficacy, the
efficiency of the production not that much into the safety. You have to look into it
carefully that how much will get this efficacy, not the safety to that extent x x x.
Second point x x x there is this already mentioned that European Union there is no
consensus, x x x they have published and submitted the systemic list of genetically
modified crop need for new approach in risk assessment. So that is what is needed.
There is another article, how does scientific risk assessment of GM crop fit within wider
risk analysis, x x x This is genetic engineering. The production process is very precise in
selecting the inserted gene but not in its enhancement, x x x they are never looking
into it. The second thing, they do not look into that from the laboratory condition to
what is the real life situation. They do not take that into account x x x so this
assessment protocol has to be modified or changed, x x x in the IAASTD or
International Assessment of Agricultural Knowledge, Science and Technology for
Development. There is a supreme body, so many nations, so many experts, scientists x
x x. Only sustainable agricultural practice and that is the only alternative. This GM
technology is not going to help them x x x In my country also, when the BT toxin
evaluation was there, everybody was telling that this is pro-poor, this is scale neutral
so, everybody will be benefitted by that. So, we started questioning, x x x "What are
the actual economic analysis indeed? Just show me". Then, they come up with an
answer. Scale neutral means that even small farmers initially wanted BT cotton and big
farmers also wanted BT cotton. They are partisans. It is not the economic benefit
because, economically, it is not going to be beneficial so it is very much scale
dependent its benefit. So, only the big farmers, large farmers and x x x the vegetable
field you never can give separation. Chances you never can give refuge. The 1/5 of the
land given for growing pests so that you cannot do. So it cannot help technology. They
have developed this technology for partisan large scale farming to completely
automated for BT technology where no label will be there. But the failed experiments,
the contracts whose patent will be over within 2-3 years, they are testing them in our
country. So that is the bottom line.
xxxx
Chairperson: chanRoblesvirtualLawlibrary
The issue that the Court is really interested to resolve is whether or not the conduct of
the field trial of BT Talong by the respondents has violated or has threatened to violate
the right of the people to a balanced and healthful ecology. Is there absolute certainty
that it has not so violated such right. Because that is the requirement for applying or
not applying the precautionary principle, x x x
Chairperson: chanRoblesvirtualLawlibrary
Well, quite certain, your Honor, because we have placed all the necessary measures
and they did not show us, you know, there is no evidence of harm that has been shown
to this Court. There is no evidence at all.
Chairperson: chanRoblesvirtualLawlibrary
As shown by the foregoing, the hot tub hearing has not yielded any consensus on the
points of contention between the expert witnesses, i.e., the safety of Bt talong to
humans and the environment. Evidently, their opinions are based on contrasting
findings in hundreds of scientific studies conducted from the time Bt technology was
deployed in crop farming. These divergent views of local scientists reflect the continuing
international debate on GMOs and the varying degrees of acceptance of GM technology
by states especially the developed countries (USA, EU, Japan, China, Australia, etc.).
Before proceeding to the current state of global GMO research, we briefly address the
strong objection of petitioners to the CA's reliance on the research conducted by Prof.
Seralini, the French scientist whose study was published in September 2012 in Food
and Chemical Toxicology, which was criticized as a "controversial feeding study."
Seralini studied rats consuming Monsanto's Roundup Ready treated corn for two years
(using the same kind of rats prone to tumors used by Monsanto in obtaining original
approval for its product and the same methodologies, but did it for 2 years which is
longer than the 90-day experiment period done by Monsanto). The rats formed massive
cancerous tumors. All three test groups of rats, with 10 rats in each group, died more
frequently, suffered from liver problems, and had a pronounced number of tumors
specifically with grotesque mammary and testicular tumors.96
Seralini's findings created an uproar and the study was expunged from the publication
in November 2013 even though the Editor-in-Chief found no evidence of fraud or
intentional misrepresentation of the data. Seralini stood by his work and further
conducted similar laboratory experiments. Critics faulted the experimental method,
saying the number of rats studied was too small and their diet was skewed when
compared with their natural food intake. But over 300 scientists condemned the
retraction, they said that the retraction lacked scientific integrity and requested to
reinstate the study. Last June 2014, Seralini's controversial study was republished and
has passed a third peer review arranged by the journal that is republishing the
study, Environmental Sciences Europe. The republished version contains extra material
addressing criticisms of the original publication and the raw data underlying the study's
findings, and accompanied by a separate commentary by Prof. Seralini's team
describing the lobbying efforts of GMO crop supporters to force the editor of the Food
and Chemical Toxicology to retract the original publication.97
The aforesaid incident serves to underscore the crucial role of scientists in providing
relevant information for effective regulation of GMOs. There can be no argument that
"[s]ince scientific advice plays a key role in GMO regulations, scientists have a
responsibility to address and communicate uncertainty to policy makers and the
public."98
It has been pointed out that the crux of the controversy surrounding GMOs lies in the
very nature of the technology itself. The process of combining inter-species genes,
which is called recombinant DNA technology, does not have the checks and balances
that are imposed by nature in traditional breeding. Because of this there is a risk of
genetic instability. This means that no one can make any accurate predictions about the
long-term effects of GMOs on human beings and the environment. Extensive testing in
this regard is either very expensive or impractical, and there is still a great deal about
the process that scientists do not understand.100
The basic concepts for the safety assessment of foods derived from GMOs have been
developed in close collaboration under the auspices of the Organization for Economic
Co-operation and Development (OECD) and the United Nations World Health
Organization (WHO) and Food and Agricultural Organization (FAO). The OECD's group
of experts on biosafety recommended conducting the safety assessment of a GM food
on case-by-case basis through comparison to an existing food with a long history of
safe use. Thus, the concept of substantial equivalence was developed that is widely
used by national and international agencies, including the US Food and Drug
Administration (FDA), the WHO, OECD and the FAO.101
"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)."102 The
safety assessment of a genetically modified food is directed by the results of a
comparison between the genetically modified food and its conventional counterpart. It
follows a stepwise process aided by a series of structured questions. Factors taken into
account in the safety assessment include:
• identity;
• source;
• composition;
• effects of processing/cooking;
• transformation process;
• the recombinant DNA (e.g. stability of insertion, potential for gene transfer);
• potential toxicity;
• potential allergenicity;
• possible secondary effects from gene expression or the disruption of the host DNA or
metabolic pathways, including composition of critical macro, micro-nutrients, anti-
nutrients, endogenous toxicants, allergens, and physiologically active substances; and,
• potential intake and dietary impact of the introduction of the genetically modified
food.103
ChanRoblesVirtualawlibrary
The above factors are particularly pertinent to the assessment of foods derived from
genetically modified plants.104 However, the concept of substantial equivalence as the
starting point of risk assessment was criticized for being "unscientific and arbitrary" and
"intentionally vague and ill-defined to be as flexible, malleable, and open to
interpretation as possible." It is likewise argued that "comparisons are designed to
conceal significant changes resulting from genetic modifications," "the principle is weak
and misleading even when it does not apply, effectively giving producers carte
blanche", and that there is insufficiency of background information for assessing
substantial equivalence. A paper presented at a WHO workshop pointed out that the
main difficulty associated with the biosafety assessment of transgenic crops is the
unpredictable nature of transformation. This unpredictability raises the concern that
transgenic plants will behave in an inconsistent manner when grown commercially.105
The method of testing GM foods was further described as inadequate, as currently the
testing procedures consist almost exclusively of specific chemical and biochemical
analytical procedures designed to quantitate a specific nutrient or a specific toxin or
allergen. It was noted that in actual practice, the investigator compares only selected
characteristics of the genetically engineered food to those of its non-genetically
engineered counterpart. These testing schemes are viewed as completely incapable of
detecting unsuspected or unanticipated health risks that are generated by the process
of genetic engineering itself. Hence, clinical tests are recommended because only such
tests have the broad specificity and relevance to human physiology needed to detect
the wide range of allergens and toxins that might result from unexpected side-effects of
the genetic engineering process.106
In another review article, it was pointed out that since a genetic modification is aimed
at introducing new traits into organisms, the result will always be a different
composition of genes and proteins. The most reasonable interpretation therefore is that
a food derived from a GMO is considered substantially equivalent to its traditional
counterpart if the genetic modification has not resulted in intended or unintended
alterations in the composition of relevant nutrients and inherent toxicants of the
organism, and that the new genes and proteins have no adverse impact on the dietary
value of the food and do not therefore pose any harm to the consumer or the
environment. It was thus concluded that establishing substantial equivalence is not a
safety assessment in itself, but is a pragmatic tool to analyze the safety of a new food,
and hence in the testing of new foods, the latest scientific methods have to be used. All
conceivable efforts to protect consumers from health risks should thus be made, and at
the same time, consumers should be adequately informed about the real extent of risks
and hazards.107
The GMO global debate has so intensified that each side has accused the other camp of
mounting "paid advocacy" and criticizing studies adverse to their respective positions as
flawed or unscientific. Both the agri-business industry, and groups opposed to GMOs
including the organic farming industry, had utilized enormous resources and funds for
lobbying and media campaigns locally and internationally.
That GE farming increases crop yield has been debunked by new studies proving the
contrary. In the article, "GM Crops Do Not Increase Yield Potential," the Institute for
Responsible Technology cited reports from actual field studies in different countries
revealing downward figures for Bt crops, as summarized below:
• Bt corn took longer to reach maturity and produced up to 12% lower yields than non-
GM counterparts.
• Evidence for the "yield drag" of Roundup Ready soybeans has been known for over a
decade - with the disruptive effect of the GM transformation process accounting for
approximately half the drop in yield.
A critical observation was made on the argument that there is not enough evidence to
reject the hypothesis that GMO and GM food is safe. The fact emphasized was that
experiments designed to clarify potential adverse effects on health or the environment
are nearly absent in peer-reviewed journals. Scientific uncertainty, omitted research
areas, and lack of basic knowledge crucial to risk assessments have become apparent.
The present uncertainty warrants further research and it has been demonstrated that
there is a risk of bias relying on hypotheses that dominate mainstream science. There is
therefore a need for independent research that is without prejudice and unbiased by
economic and professional interests.113 In another article it was noted that the clinical
trials carried out to ensure that negative externalities do not affect humans and the
environment are conducted by the same private firms that created the products, raising
conflict of interest concerns.114
While existing literature on health effects of GM foods indicates that they are generally
safe, and similar conclusions have been drawn by government agencies and scientific
organizations such as FAO/WHO and Society of Toxicology, a growing number of
independent scientists have spoken strongly against such generalizations from limited
research mostly sponsored by biotech companies.
On May 10, 2003, dozens of prominent scientists from various disciplines banded
together as an Independent Science Panel on GM at a public conference in London. On
June 15, 2003, they released a Final Report116 as their contribution to the National GM
Debate in UK. In a summary117 of the final report, these scientists declared the
following:
The Case for a GM-Free Sustainable World - A Summary
Why GM-Free?
o United States lost an estimated $12 billion over GM crops amid worldwide rejection
o High risk future for agbiotech: "Monsanto could be another disaster waiting to happen
for investors"
o Transgenic lines unstable: "most cases of transgene inactivation never reach the
literature"
o Glyphosate-tolerant weeds plague GM cotton and soya fields, atrazine back in use
o Pollen remains airborne for hours, and a 35 mile per hour wind speed is unexceptional
o GM crops have not been proven safe: regulation was fatally flawed from the start
o The principle of 'substantial equivalence', vague and ill defined, gave companies
complete licence in claiming GM products 'substantially equivalent' to non-GM, and
hence 'safe'
o Despite the paucity of credible studies, existing findings raise serious safety concerns
o 'Growth-factor-like' effects in the stomach and small intestine of young rats were
attributed to the transgenic process or the transgenic construct, and may hence be
general to all GM food
o Bt proteins, incorporated into 25% of all GM crops worldwide, are harmful to many
non-target insects, and some are potent immunogens and allergens for humans and
other mammals
o Food crops are increasingly used to produce pharmaceuticals and drugs, including
cytokines known to suppress the immune system, or linked to dementia, neurotoxicity
and mood and cognitive side effects; vaccines and viral sequences such as the 'spike'
protein gene of the pig coronavirus, in the same family as the SARS virus linked to the
current epidemic; and glycoprotein gene gpl20 of the AIDS virus that could interfere
with the immune system and recombine with viruses and bacteria to generate new and
unpredictable pathogens.
o Crops engineered with 'suicide' genes for male sterility, promoted as a means of
preventing the spread of transgenes, actually spread both male sterility and herbicide
tolerance traits via pollen.
o Glufosinate ammonium and glyphosate, used with herbicide tolerant GM crops that
currently account for 75% of all GM crops worldwide, are both systemic metabolic
poisons
o Glyphosate is the most frequent cause of complaints and poisoning in the UK, and
disturbances to many body functions have been reported after exposures at normal use
levels; glyphosate exposure nearly doubled the risk of late spontaneous abortion, and
children born to users of glyphosate had elevated neurobehavioral defects; glyphosate
retards development of the foetal skeleton in laboratory rats, inhibits the synthesis of
steroids, and is genotoxic in mammals, fish and frogs; field dose exposure of
earthworms caused at least 50 percent mortality and significant intestinal damage
among surviving worms; Roundup (Monsanto's formulation of glyphosate) caused cell
division dysfunction that may be linked to human cancers.
o The most insidious dangers of genetic engineering are inherent to the process; it
greatly enhances the scope and probability of horizontal gene transfer and
recombination, the main route to creating viruses and bacteria that cause disease
epidemics.
o Disease-causing viruses and bacteria and their genetic material are the predominant
materials and tools of genetic engineering, as much as for the intentional creation of
bio-weapons.
o Transgenic DNA from plants has been taken up by bacteria both in the soil and in the
gut of human volunteers; antibiotic resistance marker genes can spread from
transgenic food to pathogenic bacteria, making infections very difficult to treat.
o Transgenic DNA known to survive digestion in the gut and to jump into the genome of
mammalian cells, raising the possibility for triggering cancer
o Feeding GM products such as maize to animals may carry risks, not just for the
animals but also for human beings consuming the animal products
o Evidence suggests that transgenic constructs with the CaMV 35S promoter could be
especially unstable and prone to horizontal gene transfer and recombination, with all
the attendant hazards: gene mutations due to random insertion, cancer, re-activation
of dormant viruses and generation of new viruses.
More recently, in 2013, the European Network of Scientists for Social and
Environmental Responsibility (ENSSER), an international group of more than 90
scientists, academics and physicians, released a statement that there is no scientific
consensus on the safety of GM foods and crops.121 The statement122 is herein
reproduced:
10/21/13
Statement: No scientific consensus on GMO safety
We feel compelled to issue this statement because the claimed consensus on GMO
safety does not exist. The claim that it does exist is misleading and misrepresents the
currently available scientific evidence and the broad diversity of opinion among
scientists on this issue. Moreover, the claim encourages a climate of complacency that
could lead to a lack of regulatory and scientific rigour and appropriate caution,
potentially endangering the health of humans, animals, and the environment.
Science and society do not proceed on the basis of a constructed consensus, as current
knowledge is always open to well-founded challenge and disagreement. We endorse the
need for further independent scientific inquiry and informed public discussion on GM
product safety and urge GM proponents to do the same.
Some of our objections to the claim of scientific consensus are listed below.
A separate review of animal feeding studies that is often cited as showing that GM
foods are safe included studies that found significant differences in the GM-fed animals.
While the review authors dismissed these findings as not biologically significant, the
interpretation of these differences is the subject of continuing scientific debate and no
consensus exists on the topic.
Rigorous studies investigating the safety of GM crops and foods would normally involve
animal feeding studies in which one group of animals is fed GM food and another group
is fed an equivalent non-GM diet. Independent studies of this type are rare, but when
such studies have been performed, some have revealed toxic effects or signs of toxicity
in the GM-fed animals. The concerns raised by these studies have not been followed up
by targeted research that could confirm or refute the initial findings.
The lack of scientific consensus on the safety of GM foods and crops is underlined by
the recent research calls of the European Union and the French government to
investigate the long-term health impacts of GM food consumption in the light of
uncertainties raised by animal feeding studies. These official calls imply recognition of
the inadequacy of the relevant existing scientific research protocols. They call into
question the claim that existing research can be deemed conclusive and the scientific
debate on biosafety closed.
It is often claimed that "trillions of GM meals" have been eaten in the US with no ill
effects. However, no epidemiological studies in human populations have been carried
out to establish whether there are any health effects associated with GM food
consumption. As GM foods are not labelled in North America, a major producer and
consumer of GM crops, it is scientifically impossible to trace, let alone study, patterns of
consumption and their impacts. Therefore, claims that GM foods are safe for human
health based on the experience of North American populations have no scientific basis.
3. Claims that scientific and governmental bodies endorse GMO safety are
exaggerated or inaccurate
Claims that there is a consensus among scientific and governmental bodies that GM
foods are safe, or that they are no more risky than non-GM foods, are false.
For instance, an expert panel of the Royal Society of Canada issued a report that was
highly critical of the regulatory system for GM foods and crops in that country. The
report declared that it is "scientifically unjustifiable" to presume that GM foods are safe
without rigorous scientific testing and that the "default prediction" for every GM food
should be that the introduction of a new gene will cause "unanticipated changes" in the
expression of other genes, the pattern of proteins produced, and/or metabolic activities.
Possible outcomes of these changes identified in the report included the presence of
new or unexpected allergens.
A report by the British Medical Association concluded that with regard to the long-term
effects of GM foods on human health and the environment, "many unanswered
questions remain" and that "safety concerns cannot, as yet, be dismissed completely on
the basis of information currently available". The report called for more research,
especially on potential impacts on human health and the environment.
Moreover, the positions taken by other organizations have frequently been highly
qualified, acknowledging data gaps and potential risks, as well as potential benefits, of
GM technology. For example, a statement by the American Medical Association's
Council on Science and Public Health acknowledged "a small potential for adverse
events ... due mainly to horizontal gene transfer, allergenicity, and toxicity" and
recommended that the current voluntary notification procedure practised in the US prior
to market release of GM crops be made mandatory. It should be noted that even a
"small potential for adverse events" may turn out to be significant, given the
widespread exposure of human and animal populations to GM crops.
A statement by the board of directors of the American Association for the Advancement
of Science (AAAS) affirming the safety of GM crops and opposing labelling cannot be
assumed to represent the view of AAAS members as a whole and was challenged in an
open letter by a group of 21 scientists, including many long-standing members of the
AAAS. This episode underlined the lack of consensus among scientists about GMO
safety.
An EU research project has been cited internationally as providing evidence for GM crop
and food safety. However, the report based on this project, "A Decade of EU-Funded
GMO Research", presents no data that could provide such evidence, from long-term
feeding studies in animals.
Indeed, the project was not designed to test the safety of any single GM food, but to
focus on "the development of safety assessment approaches". Only five published
animal feeding studies are referenced in the SAFOTEST section of the report, which is
dedicated to GM food safety. None of these studies tested a commercialised GM food;
none tested the GM food for long-term effects beyond the subchronic period of 90 days;
all found differences in the GM-fed animals, which in some cases were statistically
significant; and none concluded on the safety of the GM food tested, let alone on the
safety of GM foods in general. Therefore the EU research project provides no evidence
for sweeping claims about the safety of any single GM food or of GM crops in general.
A frequently cited claim published on an Internet website that several hundred studies
"document the general safety and nutritional wholesomeness of GM foods and feeds" is
misleading. Examination of the studies listed reveals that many do not provide evidence
of GM food safety and, in fact, some provide evidence of a lack of safety. For
example: chanRoblesvirtualLawlibrary
• Many of the studies are not toxicological animal feeding studies of the type that can
provide useful information about health effects of GM food consumption. The list
includes animal production studies that examine parameters of interest to the food and
agriculture industry, such as milk yield and weight gain; studies on environmental
effects of GM crops; and analytical studies of the composition or genetic makeup of the
crop.
• Among the animal feeding studies and reviews of such studies in the list, a substantial
number found toxic effects and signs of toxicity in GM-fed animals compared with
controls. Concerns raised by these studies have not been satisfactorily addressed and
the claim that the body of research shows a consensus over the safety of GM crops and
foods is false and irresponsible.
• Many of the studies were conducted over short periods compared with the animal's
total lifespan and cannot detect long-term health effects.
We conclude that these studies, taken as a whole, are misrepresented on the Internet
website as they do not "document the general safety and nutritional wholesomeness of
GM foods and feeds". Rather, some of the studies give serious cause for concern and
should be followed up by more detailed investigations over an extended period of time.
As with GM food safety, no scientific consensus exists regarding the environmental risks
of GM crops. A review of environmental risk assessment approaches for GM crops
identified shortcomings in the procedures used and found "no consensus" globally on
the methodologies that should be applied, let alone on standardized testing procedures.
Some reviews of the published data on Bt crops have found that they can have adverse
effects on non-target and beneficial organisms - effects that are widely neglected in
regulatory assessments and by some scientific commentators. Resistance to Bt toxins
has emerged in target pests, and problems with secondary (non-target) pests have
been noted, for example, in Bt cotton in China.
The Cartagena Protocol on Biosafety was negotiated over many years and implemented
in 2003. The Cartagena Protocol is an international agreement ratified by 166
governments worldwide that seeks to protect biological diversity from the risks posed
by GM technology. It embodies the Precautionary Principle in that it allows signatory
states to take precautionary measures to protect themselves against threats of damage
from GM crops and foods, even in case of a lack of scientific certainty.
Another international body, the UN's Codex Alimentarius, worked with scientific experts
for seven years to develop international guidelines for the assessment of GM foods and
crops, because of concerns about the risks they pose. These guidelines were adopted
by the Codex Alimentarius Commission, of which over 160 nations are members,
including major GM crop producers such as the United States.
The Cartagena Protocol and Codex share a precautionary approach to GM crops and
foods, in that they agree that genetic engineering differs from conventional breeding
and that safety assessments should be required before GM organisms are used in food
or released into the environment.
These agreements would never have been negotiated, and the implementation
processes elaborating how such safety assessments should be conducted would not
currently be happening, without widespread international recognition of the risks posed
by GM crops and foods and the unresolved state of existing scientific understanding.
Concerns about risks are well-founded, as has been demonstrated by studies on some
GM crops and foods that have shown adverse effects on animal health and non-target
organisms, indicated above. Many of these studies have, in fact, fed into the
negotiation and/or implementation processes of the Cartagena Protocol and Codex. We
support the application of the Precautionary Principle with regard to the release and
transboundary movement of GM crops and foods.
Conclusion
In the scope of this document, we can only highlight a few examples to illustrate
that the totality of scientific research outcomes in the field of GM crop safety is
nuanced, complex, often contradictory or inconclusive, confounded by researchers'
choices, assumptions, and funding sources, and in general, has raised more questions
than it has currently answered.
Whether to continue and expand the introduction of GM crops and foods into the human
food and animal feed supply, and whether the identified risks are acceptable or not, are
decisions that involve socioeconomic considerations beyond the scope of a narrow
scientific debate and the currently unresolved biosafety research agendas. These
decisions must therefore involve the broader society. They should, however, be
supported by strong scientific evidence on the long-term safety of GM crops and foods
for human and animal health and the environment, obtained in a manner that is
honest, ethical, rigorous, independent, transparent, and sufficiently diversified to
compensate for bias.
Decisions on the future of our food and agriculture should not be based on misleading
and misrepresentative claims that a "scientific consensus" exists on GMO safety.123 ChanRoblesVirtualawlibrary
One of the most serious concerns raised against GM crops is that expressed by one of
our political analysts now serving in Congress, viz:
x x x patented GMO seeds concentrate power in the hands of a few biotech corporations
and marginalize small farmers. As the statement x x x of the 81 members of the World
Future Council put it, "While profitable to the few companies producing them, GMO
seeds reinforce a model of farming that undermines sustainability of cash-poor farmers,
who make up most of the world's hungry. GMO seeds continue farmers' dependency on
purchased seed and chemical inputs. The most dramatic impact of such dependency is
in India, where 270,000 farmers, many trapped in debt for buying seeds and chemicals,
committed suicide between 1995 and 2012."124 ChanRoblesVirtualawlibrary
In sum, current scientific research indicates that the biotech industry has not
sufficiently addressed the uncertainties over the safety of GM foods and crops.
Writ petitions were lodged before the Supreme Court of India to stop the release into
the environment of Bt brinjal (Aruna Rodrigues and Ors, etc. vs. Union of India). The
Court formed a Technical Evaluation Committee (TEC) composed of experts nominated
by the parties to undertake a comprehensive evaluation of the feasibility of allowing the
open field trials of Bt brinjal and submit a final report, and in the event the TEC is
unable to submit said final report, it was directed instead to submit an interim report
within the period set by the Court on the following issue: Whether there should or
should not be any ban, partial or otherwise, upon conducting of open field tests of the
GMOs? In the event open field trials are permitted, what protocol should be followed
and conditions, if any, that may be imposed by the Court for implementation of open
field trials." The Court also directed that the TEC would be free to review report or
studies authored by national and international scientists if it was necessary.
In its Interim Report dated October 17, 2012, the TEC recommended that, in view of its
findings, all field trials should be stopped until certain conditions have been met. A Final
Report126 was eventually submitted to the Court which noted weaknesses in the
conditions imposed by the regulatory agencies for conduct of field trials, as follows: 1)
post-release monitoring, an important aspect of environmental and health safety (if the
GE crop is consumed as food) is not given adequate attention; 2) the importance of
need and socio-economic impact assessment of GM products as one of the criteria that
should be applied in the evaluation at an early stage; and 3) need for additional tests
not currently done such as long-term feeding studies for assessment of chronic and
intergeneration toxicity in small animals, genomewide expression analysis in the
toxicity studies to screen for possible unintended effects on host physiology. It was
recommended that a moratorium on field trials of herbicide tolerant crops until the
issue had been examined by an independent committee, and also noted that said
technology may not be suitable in the Indian socio-economic context due to possible
impact of extensive use of broad spectrum herbicides on the environmental biodiversity
and smaller average farm size. Examination of the safety dossier of Bt brinjal indicated
certain concerns on the data, which had not been addressed in the course of regulatory
testing leading to approval due to lack of full-time qualified personnel for the purpose.
Overall, it was found that the quality of information in several of the applications is far
below what would be expected and required for rigorous evaluation by a regulatory
body and is unlikely to meet international regulatory guidelines.
On the mechanism of CrylAc proteins, the TEC cited studies showing that it is possible
under certain conditions for CrylAc protein to kill insects that lack the cadherin receptor.
Also, while it is generally believed that Cry toxins do not exert an effect on vertebrates
as vertebrates lack the receptor for Cry toxins, two studies (one in mice and the other
in cows) have provided evidence that Cry proteins can bind to mammalian intestinal
epithelial cells. The report also discussed the emergence of resistance in insect pests,
health and food safety of Bt transgenics, and herbicide tolerant crops and their effect
on biodiversity and the environment. Specific recommendations were made to address
the foregoing issues and the report concluded that:
The release of a GM crop into its area of origin or diversity has far greater ramifications
and potential for negative impact than for other species. To justify this, there needs to
be extraordinarily compelling reasons and only when other choices are not available.
GM crops that offer incremental advantages or solutions to specific and limited
problems are not sufficient reasons to justify such release. The TEC did not find any
such compelling reasons under the present conditions. The fact is that unlike the
situation in 1960s there is no desperate shortage of food and in fact India is in a
reasonably secure position. The TEC therefore recommends that release of GM crops for
which India is a centre of origin or diversity should not be allowed.127
ChanRoblesVirtualawlibrary
As earlier mentioned, the conduct of field trials for GE plants and crops in our country is
governed primarily by DAO 08-2002 and implemented by the DA through the BPI.
Petitioners EMB, BPI and FPA all maintain there was no unlawful deviation from its
provisions and that respondents so far failed to present evidence to prove their claim
that Bt talong field trials violated environmental laws and rules.
Within the DA-BPI, it is the Scientific and Technical Review Panel (STRP) which, as an
advisory body, was 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 Order 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,
feed to human health and the environment based on available scientific and technical
information."
DAO 08-2002 supplements the existing guidelines on the importation and release into
the environment of products of modern biotechnology by institutionalizing existing
operational arrangements between DA-BPI and the NCBP. Effective July 2003,
applications for field test are received and processed by DA-BPI, but the approval
process for projects on contained use remains under the supervision of NCBP. A
mandatory risk assessment of GM plant and plant products is required prior to
importation or release into the environment. Experiments must first be conducted
under contained conditions, then the products are tested in field trials the product is
reviewed for commercial release. Risk assessment is done according to the principles
provided for by the Cartagena Protocol on Biosafety. Risk assessment is science-based,
carried out on a case by case manner, targets a specific crop and its transformation
event, adopts the concept of substantial equivalence in identifying risk, allows review,
and provides that the absence of scientific information or consensus should not be
interpreted to indicate the absence or presence and level of risk.128
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. EO 514130 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.131 The objective of the NBF is to "[e]nhance the
decision-making system on the application of products of modern biotechnology to
make it more efficient, predictable, effective, balanced, culturally appropriate, ethical,
transparent and participatory".132 Thus, "the socio-economic, ethical, and cultural
benefit and risks of modern biotechnology to the Philippines and its citizens, and in
particular on small farmers, indigenous peoples, women, small and medium enterprises
and the domestic scientific community, shall be taken into account in implementing the
NBF."133 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 process.134
Most important, the NBF requires the use of precaution, as provided in Section 2.6
which reads:
2.6 Using Precaution. -In accordance with Principle 15 of the Rio Declaration of 1992
and the relevant provisions of the Cartagena Protocol on Biosafety, in particular Articles
1, 10 (par. 6) and 11 (par. 8), the precautionary approach shall guide biosafety
decisions. The principles and elements of this approach are hereby implemented
through the decision-making system in the NBF;
The NBF contains general principles and minimum guidelines that the concerned
agencies are expected to follow and which their respective rules and regulations must
conform with. In cases of conflict in applying the principles, the principle of protecting
public interest and welfare shall always prevail, and no provision of the NBF shall be
construed as to limit the legal authority and mandate of heads of departments and
agencies to consider the national interest and public welfare in making biosafety
decisions.135
As to the conduct of risk assessment to identify and evaluate the risks to human health
and the environment, these shall be guided by the following:
5.2.1 Principles of Risk Assessment. - The following principles shall be followed
when performing a RA to determine whether a regulated article poses significant risks
to human health and the environment: chanRoblesvirtualLawlibrary
5.2.1.1 The RA 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;
5.2.1.2 Lack of scientific knowledge or scientific consensus shall not be interpreted as
indicating a particular level of risk, an absence of risk, or an acceptable risk;
5.2.1.3 The identified characteristics of a regulated article and its use which have the
potential to pose significant risks to human health and the environment shall be
compared to those presented by the non-modified organism from which it is derived
and its use under the same conditions;
5.2.1.4 The RA shall be carried out case-by-case and on the basis of transformation event.
The required information may vary in nature and level of detail from case to case
depending on the regulated article concerned, its intended use and the receiving
environment; and,
5.2.1.5 If new information on the regulated article and its effects on human health and the
environment becomes available, and such information is relevant and significant, the
RA shall be readdressed to determine whether the risk has changed or whether there
is a need to amend the risk management strategies accordingly.
7.1 Scope of Public Participation. - Public participation shall apply to all stages of
the biosafety decision-making process from the time the application is
received. For applications on biotechnology activities related to research and
development, limited primarily for contained use, notice of the filing of such application
with the NCBP shall be sufficient, unless the NCBP deems that public interest and
welfare requires otherwise.
7.2 Minimum Requirements of Public Participation. - In conducting public
participation processes, the following minimum requirements shall be followed: chanRoblesvirtualLawlibrary
7.2.2 Adequate and reasonable time frames for public participation procedures. Such
procedures should allow relevant stakeholders to understand and analyze the benefits
and risks, consult with independent experts, and make timely interventions. Concerned
departments and agencies shall include in their appropriate rules and regulations
specific time frames for their respective public participation processes, including setting
a minimum time frame as may be appropriate;
7.2.3 Public consultations, as a way to secure wide input into the decisions that are to
be made. These could include formal hearings in certain cases, or solicitation of public
comments, particularly where there is public controversy about the proposed activities.
Public consultations shall encourage exchanges of information between applicants and
the public before the application is acted upon. Dialogue and consensus-building among
all stakeholders shall be encouraged. Concerned departments and agencies shall specify
in their appropriate rules and regulations the stages when public consultations are
appropriate, the specific time frames for such consultations, and the circumstances
when formal hearings will be required, including guidelines to ensure orderly
proceedings. The networks of agricultural and fisheries councils, indigenous
peoples and community-based organizations in affected areas shall be utilized;
Significantly, while petitioners repeatedly argued that the subject field trials are not
covered by the EIS law, EO 514 clearly mandates that concerned departments and
agencies, most particularly petitioners DENR-EMB, BPI and FPA, make a determination
whether the EIS system should apply to the release of GMOs into the environment and
issue joint guidelines on the matter.
The Philippine EIS System (PEISS) is concerned primarily with assessing the direct and
indirect impacts of a project on the biophysical and human environment and ensuring
that these impacts are addressed by appropriate environmental protection and
enhancement measures. It "aids proponents in incorporating environmental
considerations in planning their projects as well as in determining the environment's
impact on their project." There are six stages in the regular EIA process. The proponent
initiates the first three stages while the EMB takes the lead in the last three stages.
Public participation is enlisted in most stages.136
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)
All government agencies as well as private corporations, firms and entities who intend
to undertake activities or projects which will affect the quality of the environment are
required to prepare a detailed Environmental Impact Statement (EIS) prior to
undertaking such development activity.138 An environmentally critical project (ECP) is
considered by the EMB as "likely to have significant adverse impact that may be
sensitive, irreversible and diverse" and which "include activities that have significant
environmental consequences."139 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.
During the hearing at the CA, Arty. Segui of the EMB was evasive in answering
questions on whether his office undertook the necessary evaluation on the possible
environmental impact of Bt talong field trials subject of this case and the release of
GMOs into the environment in general. While he initially cited lack of budget and
competence as reasons for their inaction, he later said that an amendment of the law
should be made since projects involving GMOs are not covered by Proclamation No.
2146140. Pertinent portions of his testimony before the CA are herein quoted:
xxxx
Let us go back Mr. Witness to your answer in Question No. 5 regarding the list under
the PEISS law. Granting Mr. Witness that a certain project or undertaking is not
classified as environmentally critical project, how would you know that
the BT talong field testing is not located in an environmentally critical area this time?
As far as my recollection can serve me, in a reading of the Petition itself, somewhere
along the Petition, petitioners never alleged that the project, the subject matter rather
of this instant petition, is within an environmentally critical project.
Personally I have conferred with our personnel from the Environmental Impact
Assessment Division and they intimated to me that the locations of the project, rather
of this subject matter of the instant petition, not within any declared environmentally
critical area.
In other words, you are aware of the area where the BT Talong experiments are being
conducted. Is that the premise?
Judging from previous discussions we had . . . judging from the Petition, and showing it
to the as I said personnel from Environmental Impact Division at our office, as I said
they intimated to me that it's not within declared environmentally critical area.
That being the case, you did not act further? [You] did not make any further
evaluation, on whether the activity has an environmental impact? Is that the
correct premise?
Well Your Honors I may be the Chief of the Legal Division of the EMB, I handle more of
the legal aspects of the Bureau's affairs. But when it comes to highly technical matters,
I have to rely on our technical people especially on environmentally impact assessment
matters.
ATTY. SORIANO: chanRoblesvirtualLawlibrary
I will just ask him another question Your Honors. So did the Department of Agriculture
Mr. Witness coordinate with your Office with regard the field testing of BT Talong?
Mr. Witness, the question is did the Department of Agriculture coordinate with your
Office with regard the field testing of BT Talong as required under the law?
The witness in effect said he does not know, he's not in a position to answer.
xxxx
Did the EMB Mr. Witness perform such evaluation in the case of BT Talong field
testing?
Your Honor that is speculative, the witness has just answered a while ago that the EMB
has not yet received any project with respect to that Your Honor. So the witness would
not be in a position to answer that Your Honors.
The earlier answer Your Honor of the witness is in general terms. My second question,
my follow-up question is specifically Your Honor the BT talong field testing.
Well from where I sit Your Honors, it would appear that it could be categorized as
unclassified...
HON. J. VALENZUELA: chanRoblesvirtualLawlibrary
Unclassified?
As the section will initially provide. But there must be prior ... may I continue to harp
on that Your Honors. There must be prior ... let's say conditions ... there must be prior
evaluation and assessment just the same by the EMB.
So initially you call it unclassified and then you say prior to...
Yes please.
And Mr. Witness you also said that the agency the EMB is without the capability to
evaluate the projects such as this one in particular?
So therefore, when you say initially it's unclassified and then you're saying
afterwards the EMB needs evaluation but then you're saying the EMB is
without any capability to evaluate then what happens?
Well Your Honors, I did not draft the regulation myself. As the Chief of the Legal of the
EMB that's how we interpret it. But the truth of the matter is with all
pragmatism we don't have the resources as of now and expertise to do just
that.
So in other words you admit that the EMB is without any competence to make
a categorical or initial examination of this uncategorized activity, is that what
you mean?
What do you think would prompt your office to make such initial examination?
Well executive fee at the usual dictates ... the Secretary of the DENR probably even by
request of the parties concerned.
So that means you are waiting for a request? Are you not? Proactive in this activity in
performing your obligations and duties?
Well Your Honors, the national budget if I may ... I attend budget hearings myself. The
budget for the environment is hardly ... the ratio is ... if we want to protect
indeed the environment as we profess, with all due respect if Congress speaks
otherwise.
May I interrupt, can we go into specifics. From what I have read so far, under No. 2 of
your Judicial Affidavit, [you] are saying that the EMB is tasked in advising the DENR on
matters related to environmental management, conservation and pollution control,
right?
Thereafter you stated that you are tasked mainly with PD 1586 which refers to
Environmental Critical Areas of Projects and more specifically focused on Proclamation
No. 2146. With respect to this BT Talong, you mentioned that this is at first is
uncategorized, it's not within?
But you did mention that under the rules and regulations, even in an uncategorized
activity, pertaining to the environment, your Office has the mandate and then you later
say that your Office is without competence, do I follow your line of standing?
Yes, but under the implementing rules your Office has the mandate to act on other
unclassified activities and you answered that your Office has no competence.
Proclamation 2146 executed by then Pres. Marcos, the IRR pointed to was executed by
I believe the Secretary of DENR. We need an amendment of 2146.141 (Emphasis
supplied)
The foregoing stance 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.
xxxx
xxxx
These concerned departments shall enter into agreement on the sharing of financial and
technical resources to support the NCBP and its Secretariat.
All told, petitioners government agencies clearly failed to fulfil their mandates in the
implementation of the NBF.
10
DECISION PROCEDURE
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Article
11
OR FOR PROCESSING
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Annex III
RISK ASSESSMENT
General principles
xxxx
4. Lack of scientific knowledge or scientific consensus should not necessarily be
interpreted as indicating a particular level of risk, an absence of risk, or an acceptable
risk.
The precautionary principle applies when the following conditions are met145:
there exist scenarios (or models) of possible harm that are scientifically
reasonable (that is based on some scientifically plausible reasoning);
there is a need to act now, since effective counteraction later will be made
significantly more difficult or costly at any later time.
The Rules likewise incorporated the principle in Part V, Rule 20, which states:
PRECAUTIONARY PRINCIPLE
The constitutional right of the people to a balanced and healthful ecology shall be given
the benefit of the doubt.
Assessing the evidence on record, as well as the current state of GMO research
worldwide, the Court finds all the three conditions present in this case - uncertainty, the
possibility of irreversible harm and the possibility of serious harm.
Eggplants (talong) are a staple vegetable in the country and grown by small-scale
farmers, majority of whom are poor and marginalized. While the goal of increasing crop
yields to raise farm incomes is laudable, independent scientific studies revealed
uncertainties due to unfulfilled economic benefits from Bt crops and plants, adverse
effects on the environment associated with use of GE technology in agriculture, and
serious health hazards from consumption of GM foods. For a biodiversity-rich country
like the Philippines, the natural and unforeseen consequences of contamination and
genetic pollution would be disastrous and irreversible.
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.
We have found the experience of India in the Bt brinjal field trials - for which an
indefinite moratorium was recommended by a Supreme Court-appointed committee till
the government fixes regulatory and safety aspects - as relevant because majority of
Filipino farmers are also small-scale farmers. Further, the precautionary approach
entailed inputs from all stakeholders, including the marginalized farmers, not just the
scientific community. This proceeds from the realization that acceptance of uncertainty
is not only a scientific issue, but is related to public policy and involves an ethical
dimension.148 For scientific research alone will not resolve all the problems, but
participation of different stakeholders from scientists to industry, NGOs, farmers and
the public will provide a needed variety of perspective foci, and knowledge.149
Finally, while the drafters of the NBF saw the need for a law to specifically address the
concern for biosafety arising from the use of modern biotechnology, which is deemed
necessary to provide more permanent rules, institutions, and funding to adequately
deal with this challenge,150 the matter is within the exclusive prerogative of the
legislative branch.
WHEREFORE, the petitions are DENIED. The Decision dated May 17, 2013 of the
Court of Appeals in CA-G.R. SP No. 00013 is hereby MODIFIED, as follows: chanRoblesvirtualLawlibrary
3. 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.
No pronouncement as to costs.
SO ORDERED. chanroblesvirtuallawlibrary
Sereno, C.J., Leonardo-De Castro, Peralta, Bersamin, Del Castillo, Perez, Mendoza,
Reyes, and Perlas-Bernabe, JJ., concur.
Carpio, J., no part prior inhibition.
Velasco, Jr., J., pls. see Concurring Opinion.
Brion, J., on official leave.
Leonen, J., see separate concurring opinion.
Jardeleza, J., no part.
Endnotes:
1
Rollo (G.R. No. 209271), pp. 135-159. Penned by Associate Justice Isaias P. Dicdican
with Associate Justices Myra V. Garcia-Fernandez and Nina G. Antonio-Valenzuela
concurring.
2
Id. at 161-174.
3
CA rollo (Vol. VI), Annex "O" of Biotech Petition.
4
<http://www.isaaa.org/inbrief//default.asp> (visited last November 7, 2014).
5
UPLBFI, "History" <http://uplbfi.org/?page_id=231/> (visited last November 7,
2014).
6
"AN ACT TO STRENGTHEN THE UNIVERSITY OF THE PHILIPPINES AS THE NATIONAL
UNIVERSITY."
7
RA 9500, Sec. 3(c).
8
Susan R. Barnum, Biotechnology: An Introduction by 1 (1998).
9
University of the Philippines Los Baños National Institute of Molecular Biology and
Biotechnology, "About Us" <http://biotech.uplb.edu.ph/index.php/en/about-us>
(visited last November 7, 2014).
10
The Center for Media and Democracy, "GMOs in the Philippines"
<http:/www.sourcewatch.org/index.php/GMOs_in_the_Philippines>, (visited last
November 7, 2014).
11
Id. (See also CA rollo, pp. 882-884).
12
EO 514, Sec. 2.1.
13
Id., Sec. 8.
14
CA rollo (Vol. I), pp. 82-84.
15
Id. at 85-86.
16
CA rollo (Vol. II), pp. 885-886.
17
Id. at 1058-1064.
18
CA rollo (Vol. I), pp. 67-69.
18-a
Id. at 400.
19
A.M. No. 09-6-8-SC (2010).
20
CA rollo (Vol. III), p. 2026.
21
Id. at 2120-2123. UPLB was not served with the writ of kalikasan issued by this Court
nor furnished with copy of the petition of Greenpeace, et al. Its Answer, adopting the
arguments and allegations in the verified return filed by UPLBFI, was filed in the CA.
See CA Resolution dated August 17, 2012, id. at 2117-2119.
22
Id. at 2100.
23
Id. at 2312-2324.
24
CA rollo (Vol. IV), pp. 2450-2460.
25
Id. at 2864-2871.
26
Rollo (G.R. No. 209271), Vol. 1, pp. 157-158.
27
SECTION 1. Applicability. - When there is 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.
28
Rollo (GR. No. 209271), Vol. I, pp. 168-170.
29
Id. at 35-37.
30
Id. at 81.
31
Rollo (G.R. No. 209301), pp. 48-50, 53-55.
32
Rollo (G.R. No. 209271), Vol. IX, pp. 4111-4112. Citations omitted.
33
Id. at 4112-4115. Citations omitted.
34
Rollo (G.R. No. 209271), Vol. IX, p. 4115.
35
Id., Vol. XI, pp. 5715-5717.
36
Id. at 5835-5837.
37
Rollo (G.R. No. 209271), Vol. V, pp. 2386-2387.
38
Bayan Muna v. Romulo, G.R. No. 159618, February 1, 2011, 641 SCRA 244, 254,
citing David v. Macapagal-Arroyo, 522 Phil. 705, 755 (2006).
39
Id., citing Jumamil v. Cafe, 507 Phil. 455, 465 (2005).
40
Social Justice Society (SJS) v. Dangerous Drugs Board, et al., 591 Phil. 393, 404
(2008); Tatad v. Secretary of the Department of Energy, 346 Phil. 321 (1997); and De
Guia v. COMELEC, G.R. No. 104712, May 6, 1992, 208 SCRA 420, 422.
41
Kilosbayan Incorporated v. Guingona, Jr., G.R. No. 113375, May 5, 1994, 232 SCRA
110, 137.
42
G.R. No. 101083, July 30, 1993, 224 SCRA 792, 804-805.
43
Id. at 802-803.
44
Rule 2, Sec. 5 reads in part: chanRoblesvirtualLawlibrary
SEC. 5. Citizen suit. - Any Filipino citizen in representation of others, including minors
or generations yet unborn, may file an action to enforce rights or obligations under
environmental laws. x x x
45
See Annotation on A.M. 09-6-8-SC.
46
Santiago v. Court of Appeals, 348 Phil. 792, 800 (1998).
47
Barbieto v. Court of Appeals, G.R. No. 184645, October 30, 2009, 604 SCRA 825,
840.
48
Office of the Deputy Ombudsman for Luzon v. Francisco, Sr., G.R. No. 172553,
December 14, 2011, 662 SCRA 439,449, citing David v. Macapagal-Arroyo, supra note
38, at 754.
49
546 Phil. 87, 96-98 (2007).
50
See Boracay Foundation, Inc. v. Province of Aklan, G.R. No. 196870, June 26, 2012,
674 SCRA 555, 608.
51
George Acquaah, Understanding Biotechnology: an integrated and cyber-based
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52
Id. at 72.
53
Nancy Harris, Genetically Engineered Foods, (Greenhaven Press, 2004) at 5-6.
54
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57
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59
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Id. at 329-332.
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CONCURRING OPINION
VELASCO,JR., J.:
Technological and scientific advances no longer involve raw materials manipulation and
transformation. It now embraces changing the very genetic make-up of live organisms,
altering and even mixing characteristics of flora, fauna, microorganisms, among others,
for various purposes, including attempts to increase agricultural yield and improve and
develop sustainable pest control.
The Philippines is not insulated from this genetic modification of organisms as it is, in
fact, a regulated activity in this jurisdiction. But, in view of the possible dangers that
the activity poses to the biodiversity-rich environs of the country, environmental
protection in the Philippines has evolved to adapt to these progresses and is still being
further strengthened via executive, legislative, and judicial efforts.
At bar are consolidated petitions seeking the reversal of the Decision of the Court of
Appeals (CA) dated May 17, 2013, as well as its Resolution dated September 20, 2013,
in CA-G.R. SP No. 00013 which permanently enjoined the conduct of field trials for the
genetically modified eggplant, commonly known as "Bt Talong" on concerns for
biosafety.
Biosafety is a condition in which the probability of harm, injury and damage resulting
from the intentional and unintentional introduction and/or use of a regulated article is
within acceptable and manageable levels.1 "Regulated article" refers to genetically
modified organisms2 (GMOs), which are "living modified organisms" under the
Cartagena Protocol on Biosafety and refers to any living organism that possesses a
novel combination of genetic material obtained through the use of modern
biotechnology.3 Regulated articles also include the products of GMOs.4
PD 1151, which put in place the use of Environmental Impact Statements in this
jurisdiction, declares as the State's continuing policy (a) to create, develop, maintain
and improve conditions under which man and nature can thrive in productive and
enjoyable harmony with each other; (b) to fulfill the social, economic and other
requirements of present and future generations of Filipinos; and (c) to insure the
attainment of an environmental quality that is conducive to a life of dignity and well-
being.
In connection therewith, the same provision declares that "[n]o person, partnership or
corporation shall undertake or operate any such declared environmentally critical
project or area without first securing an Environmental Compliance Certificate (ECC)
issued by the President or his duly authorized representative."10
For those projects that are identified to be environmentally non-critical, Section 5 of the
same law provides that "[a]ll other projects, undertakings and areas not declared by
the Presidents as environmentally critical shall be considered as non-critical and shall
not be required to submit an environmental impact statement."
Thus and simply put, under the PEISS, if the project is itself identified to be
environmentally critical or to be undertaken at an environmentally critical area, the
proponent has to secure an ECC. If, however, the project is identified under the PEISS
as environmentally non-critical and is not to be undertaken in an environmentally
critical area, then the proponent will secure a Certificate of Non-Coverage (CNC)
instead of an ECC.
It is, however, well to note that even though a project may be certified as not covered
by the environmental impact assessment requirement, still, there is nothing that will
bar the government agencies concerned from requiring from the proponent the
adoption of additional environmental safeguards that they may deem necessary.11
Hence, before the entry of biotechnology in Philippine jurisdiction and the introduction
of GMOs to its soil, and even after such, it is the PEISS that primarily governs projects
that have or may have an impact on the country's ecological balance and makeup,
whether the project involves biotechnology or not. And it was only in 1990, or almost a
decade after the issuance of Presidential Proclamation No. 2146 identifying
environmentally critical areas and projects, when the government began regulating
Biotechnology research in the country.
In 1987, scientists from the University of the Philippines Los Banos (UPLB) and the
International Rice Research Institute (IRRI), the Quarantine Officer of the Bureau of
Plant Industry (BPI), and the Director for Crops of the Philippine Council for Agriculture,
Forestry and Natural Resources Research and Development (PCARRD), recognizing the
potential harm of the introduction of exotic species and genetic engineering, formed a
committee and formulated the biosafety protocols and guidelines for genetic
engineering and related research activities for UPLB and IRRI researchers. The
committee went on to draft a Philippine biosafety policy, which was submitted to the
Office of the President.12
On the basis of said submission, on October 15, 1990, then President Corazon C.
Aquino signed Executive Order No. 430 (EO 430) constituting the National Committee
on Biosafety of the Philippines (NCBP) among other purposes.13 Said directive was
issued in recognition of the value of biotechnology and its high potential to improve the
quality of human life, as well as the possible concomitant risks and hazards that
biotechnology may pose to health safety, environment, and society.14
EO 430 created the National Committee on Biosafety of the Philippines (NCBP) and
vested upon it the following functions, to wit:
(a) Identify and evaluate potentials hazards involved in initiating genetic engineering
experiments or the introduction of new species and genetically engineered organisms
and recommend measures to minimize risks;
(b) Formulate and review national policies and guidelines on biosafety, such as the safe
conduct of work on genetic engineering, pests and their genetic materials for the
protection of public health, environment and personnel and supervise the
implementation thereof;
(c) Formulate and review national policies and guidelines in risk assessment of work
biotechnology, and supervise the implementation thereof;
(d) Develop working arrangements with the government quarantine services and
institutions in the evaluation, monitoring, and review of projects vis-a-vis adherence to
national policies and guidelines on biosafety;
(e) Assist in the development of technical expertise, facilities and other resources for
quarantine services and risk assessments;
(f) Recommend the development and promotion of research programs to establish risk
assessment protocols and assessment of long-term environmental effects of biological
research covered by these guidelines;
(g) Publish the results of internal deliberation and agency reviews of the committee;
(h) Hold public deliberations on proposed national policies, guidelines and other
biosafety issues;
(i) Provide assistance in the formulation, amendment of pertinent laws, rules and
regulations; and
(j) Call upon the assistance of any government agency, department, office, bureau
including government-owned and/or controlled corporations.15 ChanRoblesVirtualawlibrary
Pursuant to its mandate, the NCBP published the first version of the Philippine National
Biosafety Guidelines in 1991 (1991 Guidelines). Said Guidelines governs regulating the
importation, transfer and use of GMOs and potentially harmful exotic species in the
Philippines, with focus on potentially hazardous work performed under contained
conditions. Since the publication of the first edition, the NCBP has received and
evaluated more than eighty (80) project proposals, all of which were to be performed
under contained conditions. However, recognizing the rapid advances in other countries
in respect of field trials of selected GMOs, the NCBP decided to look into the adequacy
and relevance of the Guidelines, particularly as it relates to planned release.
In 1996, the NCBP started to review the Guidelines with the view of revising it to
address the concerns of both the scientific and environmental communities. Hence, the
second edition was issued on May 15, 1998. Series No. 3 of the second edition contains
the guidelines on the deliberate release of GMOs and Potentially Harmful Exotic Species
(PHES) into the Philippine Environment.16 Furthermore, it specifically repealed the
provisions of the 1991 Guidelines on field release of regulated materials which are
inconsistent therewith.17
From 1990 to 2002, the NCBP's scope of mandate included research and development
in the laboratory, screenhouse and in the field.18Regulation of field testing was later
removed from the NCBP's mandate when the Department of Agriculture (DA) issued
Administrative Order No. 8 (AO No. 8, s. 2002) or the "Rules and Regulations for the
Importation and Release into the Environment of Plants and Plant Products Derived
from the Use of Modern Biotechnology."
AO No. 8, s. 2002 was approved on April 3, 2002 and became operational in July
2003.19 It 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.20
Furthermore, it specifically provides that it shall not apply to the contained use of a
regulated article, which is within the regulatory supervision of the NCBP.21 With these,
the administrative order thus transferred regulation of field testing of biotech crops to
the DA's Bureau of Plant Industry (BPI), among others.22
With DA AO No. 8, s. 2002, field tests and eventual commercial propagation of biotech
crops would be handled by the DA-BPI, instead of the NCBP, starting July 2003. Thus,
DA AO 8 redefined the NCBP's tasks to focus on contained facility R & D involving
genetically modified organisms. However, NCBP continued to review and formulate
policies on biotechnology as well as review and modify the science-based risk
assessment of protocols to be used by the regulatory agencies implementing the
commercial guidelines. All applications for field tests received before July 1, 2003
remained under the supervision of the NCBP until their completion.23
EO 514 highlighted the need to enhance the existing biosafety framework to better
respond to the challenges presented by further advances in modern biotechnology and
to comply with the administrative requirements of the Cartagena Protocol on
Biosafety.24 Consistent with these, the NBF has the following objectives, viz:
2.2.1. Strengthen the existing science-based determination of biosafety to ensure the
safe and responsible use of modern biotechnology so that the Philippines and its
citizens can benefit from its application while avoiding or minimizing the risks
associated with it;
2.2.2. Enhance the decision-making system on the application of products of modern
biotechnology to make it more efficient, predictable, effective, balanced, culturally
appropriate, ethical, transparent and participatory; and
2.2.3. Serve as guidelines for implementing international obligations on biosafety.
In order to put these objectives into action, EO 514 strengthened the NCBP through the
expansion of its composition25 and functions.
4.2.4 A representative from industry appointed by the President from a list submitted
by the Secretary of Trade and Industry, serving for a term of three (3) years,
renewable for another term; and,
1. set the national scientific and technical biosafety standards on methods and
procedures for ensuring biosafety in the country, consistent with existing laws;
and
The DA was designated as the agency that shall address biosafety issues related to the
country's agricultural productivity and food security.27 Additionally, the DA was directed
to exercise such jurisdiction and other powers that it has been conferred with under
existing laws, in coordination with other concerned departments and agencies, and
consistent with the requirements of transparency and public participation as provided in
Sections 6 and 7 of the NBF. Moreover, it was mandated to take the lead in evaluating
and monitoring plant and plant products derived from the use of modern biotechnology,
as provided in Department of Agriculture Administrative Order No. 008, s. 2002.
The Department of Science and Technology (DOST), on the other hand, is to 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 decisions. It also
was tasked to ensure that such policies, measures, guidelines and decisions are made
on the basis of scientific information that is of the highest quality, multi-disciplinary,
peer-reviewed, and consistent with international standards as they evolve.28
With respect to its functions, Item 4.6, Section 4 of EO 514 provides thusly:
4.6 Powers and Functions of the NCBP. As the lead body in implementing the NBF,
the NCBP shall have the following powers and functions: chanRoblesvirtualLawlibrary
Hold public deliberations on proposed national policies, guidelines, and other biosafety
issues;
4.6.1.3 Provide assistance in the formulation, amendment of pertinent laws, rules and
regulations;
4.6.1.4 In coordination with concerned departments and agencies and consistent with
the requirements of transparency and public participation as provided in Sections 6 and
7 of the NBF, shall take the lead in periodically reviewing the NBF; Issue detailed
guidelines on the conduct of socio-economic impact evaluation of biosafety decisions;
and,
4.6.2.2 Ensure coordination among competent national authorities that have shared
mandates;
4.6.3.1 Facilitate the study and evaluation of biosafety research and control and
minimize the concomitant risks and hazards associated with the deliberate release of
regulated articles in the environment;
4.6.3.4 Develop working arrangements with the government quarantine services and
institutions in the evaluation, monitoring, and review of projects vis-a-vis adherence to
national policies and guidelines on biosafety;
4.6.3.5 Review and develop guidelines in the risk assessment of regulated articles for
contained use;
4.6.3.8 Publish the results of internal deliberations and agency reviews of the NCBP;
4.6.3.9 Hold, discussions on the comparative ecological, economic and social impacts of
alternative approaches to attain the purposes/objectives of the proposed genetic
modification products and/or services; and,
4.6.4.1 Assist in the development of technical expertise, facilities, and other resources
for quarantine services and risk assessments; and,
4.6.4.2 Take the lead in developing and implementing a national capacity- building
program for biosafety.
As to its effect on existing policies, rules, and issuances, specifically DA AO No. 8, s.
2002, it is well to note that Section 830 of EO 514 specifically provided that DA AO No.
8, s. 2002 remains to be in force and effect.
Despite the issuance, however, of EO 514, new biosafety policies or guidelines on GMO
field testing have yet to be issued. Furthermore, DA AO No. 8, s. 2002 has not been
amended. As such, it remains to be the rules that primarily govern the conduct of field
trials for genetically engineered plants and crops in our jurisdiction, as noted by
the ponencia.
As it stands, application for field testing of regulated articles is governed by Part III
(Approval Process for Field Testing of Regulated Articles) of DA AO No. 8, s. 2002,
Section 7 of which states that:
No regulated article shall be released into the environment for field testing, unless: (i)
a Permit to Field Test has been secured from the BPI; and (ii) the regulated article has
been tested under contained conditions in the Philippines. x x x
It is important, however, to emphasize that despite the issuance of DA AO No. 8, s.
2002, the NBF, and the NCBP Guidelines, other statutory requirements or those
required by agencies remain in full force and effect.31 This is bolstered by the fact
that EO 514, as mentioned by the ponencia, requires the determination by the
concerned departments or agencies of whether the Philippine Environmental Impact
Assessment (EIA) System should be applied to biosafety decisions.32 EO 514 also
requires the DENR, as a member of the NCBP, to ensure that environmental
assessments are done and impacts identified in biosafety decisions.33
Under the regulatory supervision of the NCBP, a contained experiment was started in
2007 and officially completed on March 3, 2009. The NCBP, thus, issued a Certificate of
Completion of Contained Experiment stating that "During the conduct of the
experiment, all the biosafety measures have been complied with and no untoward
incident has occurred."
After securing the necessary permits, the UPLB commenced the field testing of Bt
Talong on various dates, in the following approved sites: Kabacan, Borth Cotabato; Sta.
Maria, Pangasinan; Pili, Camarines Sur; Bago Oshiro, Davao City; and Bay, Laguna.
On April 26, 2012, respondents filed a petition for writ of kalikasan and writ of
continuing mandamus with prayer for the issuance of a Temporary Environmental
Protection Order (TEPO). They allege that the Bt Talong field trials violate their
constitutional right to a healthful and balanced ecology considering that:
5. Data from the use of Bt CrylAb maize indicate that beneficial insects have
increased mortality when fed on larvae of a maize pest, the corn borer, which
had been fed on Bt, and hence non-target beneficial species that may feed on
eggplant could be similarly affected;
6. Data from China show that the use of Bt crops (Bt cotton) can exacerbate
populations of other secondary pests;
7. The built-in pesticides of Bt crops will lead to Bt-resistant pests, thus increasing
the use of pesticides, contrary to the claims by GMO manufacturers;
8. The 200-meter perimeter pollen trap area in the field testing set by BPI is not
sufficient to stop contamination of nearby non-Bt eggplants because pollinators
such as honeybees can fly as far as four (4) kilometers and an eggplant is 48%
insect-pollinated; and
9. The field test project did not comply with the required public consultation under
Sections 26 & 27 of the Local Government Code.
The full acceptance by the project proponents of the findings in the MAHYCO Dossier
was strongly assailed on the ground that these do not precisely and adequately assess
the numerous hazards posed by Bt Talong and its field trial.
On May 2, 2012, the Court issued a writ of kalikasan against International Service for
the Acquisition of Agri-Biotech Applications, Inc. (ISAAA), EMB/BPI/FPA and UPLB,
ordering them to make a verified return within a non-extendible period often (10) days,
as provided in Sec. 8, Rule 7, of the Rules of Procedure for Environmental Cases.
ISAAA argued that the allegations regarding the safety of Bt talong as food are
irrelevant in the field trial stage as none of the eggplant will be consumed by humans or
animals, and all materials that will not be used for analyses will be chopped, boiled, and
buried following the Biosafety Permit requirements. Too, it cited a 50-year history of
safe use and consumption of agricultural products sprayed with commercial Bt microbial
pesticides and a 14-year history of safe consumption of food and feed derived
from Bt crops.
UPMFI contends that the Bt talong planted in Davao City have already been uprooted by
the City officials. And there having been no further field trials conducted thereat, there
is no violation of the constitutional rights of persons or damage to the environment with
respect to Davao City that will justify the issuance of a writ of kalikasan.
Finally, it is argued that the precautionary principle is not applicable considering that
the field testing is only a part of a continuing study being done to ensure that the field
trials have no significant impact on the environment. There is, thus, no resulting
environmental damage of such magnitude as to prejudice the life, health, or property of
inhabitants in two or more cities or provinces.
On July 10, 2012, the Court referred the case to the CA for acceptance of the return of
the writ and for hearing, reception of evidence, and rendition of judgment. The
following issues were submitted for the CA's resolution:
1. Whether or not Greenpeace, et al. have the legal standing to file the petition for
writ of kalikasan;
Under its Resolution dated October 12, 2012, the CA resolved that: chanRoblesvirtualLawlibrary
(1) Greenpeace, et al. possess the requisite legal standing to file the petition;
(2) assuming arguendo that the field trials have already been terminated, the case is
not yet moot since it is capable of repetition yet evading review; and
(3) the alleged non-compliance with environmental and local government laws present
justiciable controversies for resolution by the court.
After trial on the merits, the CA, on May 17, 2013, rendered a Decision in favor of
Greenpeace, et al., thus:
WHEREFORE, in view of the foregoing premises, Judgment is hereby rendered by
us GRANTING the petition filed in this case. The respondents are DIRECTED to:
(a) Permanently cease and desist from further conducting bt talong field trials; and
(b) Protect, preserve, rehabilitate and restore the environment in accordance with the
foregoing judgment of this Court.
No costs.
SO ORDERED.
The CA found that existing regulations issued by the DA and the DOST are insufficient
to guarantee the safety of the environment and the health of the people. It likewise
applied the precautionary principle set forth in Section 1, Rule 20 of the Rules of
Procedure for Environmental Cases, stressing the fact that the "over-all safety
guarantee of the bt talong" and whether it poses a threat to human health remain
unknown. In view of said uncertainty, the CA upheld the primacy of the people's
constitutional right to a healthful and balanced ecology.'
Then, in its September 20, 2013 Resolution, the CA rejected UPLB's argument that its
ruling violated the latter's constitutional right to academic freedom. The CA held that
the writ issued by the Court did not stop the research on Bt talong but only the
particular procedure adopted in the conduct of the field trials and only at this time when
there is yet no law in the form of a congressional enactment for ensuring its safety and
levels of acceptable risks when introduced into the environment.
The CA, in justifying its ruling, relied on the theory that the introduction of a genetically
modified plant into our ecosystem is an "ecologically imbalancing act." The CA noted
that the Bt talong is a technology involving a deliberate alteration of an otherwise
natural state of affairs, designed to alter the natural feed-feeder relationships of the
eggplant.
From the foregoing, the following issues were presented for this Court's resolution: chanRoblesvirtualLawlibrary
Anent the technical aspect of the case, it is clear from the ponencicCs lengthy
discussion that the safety or danger of introduction of GMOs, in general, to the natural
environment through field testing has yet to be settled with scientific certainty, if it
could indeed be settled. Furthermore, the subject matter of the instant petition—that is,
field testing of a GMO—is truly of a highly complex nature and this complexity is
strongly demonstrated by the fact that the matter remains to be hotly debated in the
scientific community. However, it is respectfully submitted that the instant petition can
be resolved, and the right to a balanced and healthful ecology sufficiently protected, on
a purely legal ground.
Anent the invocation of the Precautionary Principle under A.M. No. 09-6-8-SC or the
Court's Rules of Procedure for Environmental Cases, it is submitted that such is not
necessary in the instant petition since, as mentioned, it could be sufficiently settled on
purely legal grounds and without a heavy, if not complete, reliance on the scientific
aspect of the case. As correctly mentioned by the ponencia, it is an evidentiary rule that
must be applied only as a last resort. Thus, if an environmental case can be settled and
the people's environmental rights sufficiently protected without applying this principle,
then the courts should refrain from doing so.
Among the numerous issues presented for this Court's consideration are alleged neglect
or unlawful omission committed by the public respondents in connection with the
processing and evaluation of the applications for Bt talong field testing and the
applicability of the Philippine Environmental Impact Statement System (PEISS) to GMO
field trials. It is in these matters that, in my opinion, the petitioner-agencies failed.
Petitioner-agencies maintain that the subject field trials are not covered by the PEISS.
It is submitted, however, that the PEISS also covers GMO field trials on the following
grounds: chanRoblesvirtualLawlibrary
First, as previously mentioned, EO 514 clearly requires the DENR to ensure that
environmental assessments are done and impacts identified in biosafety
decisions.34 This, in itself, is a clear indication that GMO field trials fall within the
purview of our PEISS.
Under EO 514, "biosafety decisions" apply to the development, adoption and
implementation of all biosafety policies, measures and guidelines and in making
decisions concerning the research, development, handling and use,
transboundary movement, release into the environment and management of
regulated articles.35
Thus, EO 514 calls for the conduct of environmental assessments and impact
identification—which precisely is the purpose of the PEISS— whenever biosafety
decisions are to be made with respect to the research, development, handling and use,
transboundary movement, and release into the environment of regulated articles, which
are, to reiterate, GMOs. To my mind, "making [biosafety] decisions concerning the
research, development, handling and use, transboundary movement, release into the
environment and management of regulated articles" include determining the coverage
or non-coverage of a GMO field trial under the PEISS, as well as the propriety of issuing
an ECC or a CNC for a particular project.
Third, Section 4, paragraph 4.1, Article II of DAO 30, s. 2003, provides that projects
that pose potential significant impact to the environment shall be required to
secure an ECC.
Anent this possibility of negatively affecting the environs, it is argued that the
introduction of the Bt talong to the natural environment in connection with the field
trials will not adversely affect the condition of the field trial sites, banking on the
absence of documented significant and negative impact of the planting of Bt corn in the
Philippines, among others. However, it is curious that in blocking the application of the
precautionary principle, petitioners contradict this prior assertion when they maintained
that field testing is only a part of a continuing study being done to ensure that
the field trials have no significant and negative impact on the environment.
This, to my mind, only goes to show that it is erroneous for them to maintain that the
field trials in question will not adversely affect the environment when they themselves
admit that such is not yet a scientific certainty, hence the conduct of further research
on the matter. And without this certainty that the project will leave no footprint on the
natural environment, as well as a certification to that effect, it should be presumed that
the field trial poses a potential significant impact to the environment for which an ECC
is required.
Fourth, the Revised Procedural Manual for DENR AO No. 30, s. 2003 (Revised Manual)
enumerates the projects that are covered by the PEISS. Said enumeration, as
the ponencia pointed out, includes Group V (Unclassified Projects) which pertains to
those projects using new processes/technologies with uncertain impacts.36
Fifth, Item 8 of said Revised Manual, governing the EIA Report Types and Generic
Contents, requires a Project Description Report (PDR) for Group V projects, to ensure
new processes/technologies or any new unlisted project does not pose harm
to the environment. The Group Y PDR is a basis for either issuance of a CNC or
classification of the project into its proper project group.
To my mind, the above grounds should have prompted the DENR to require from the
project proponents an EIA or at the very least evaluated the project's coverage or non-
coverage as pre-condition to the allowance of the field testing. In this regard, the
DENR—as a member of the NCBP with the clear mandate of making certain
that environmental assessments are done in the conduct of GMO research, and
as the agency tasked to enforce the PEISS—may have been remiss in its duty.
It may be that there is a confusion as to the requirements before field testing a GMO
may be allowed considering that the regulation that governs applications therefor, that
is, DA AO No. 8, s. 2002, makes no mention of the necessity of an EIA or the
applicability of the PEISS. Additionally, per the NCBP's Report,37 it was pointed out that
the applicability of the PEISS to field trials was a hotly discussed issue. While securing
an ECC or a CNC was the perceived requirement for EIA in biosafety valuations, there
were those who argued that the EIA can take many years to conduct and cost millions
of pesos and could, therefore, delay field tests and discourage proponents. It was
likewise maintained that under the present practice of the NCBP, the confinement
afforded by the screenhouse and/or contained fields already provides a means to
prevent or minimize any adverse environmental impact and, thus, an EIA may not be
required.
Biosafety decisions shall be made in accordance with existing laws and the following
guidelines:chanRoblesvirtualLawlibrary
Additionally, it is but timely to clarify that DA AO No. 8, s. 2002 did not expressly state
that projects falling under its coverage are withdrawn from the operation of the PEISS.
As a matter of fact, the DENR-EMB itself recognizes that "the PEISS is
supplementary and complementary to other existing environmental
laws."43 This is further bolstered by the PEISS' role in relation to the functions of other
government agencies. In this regard, it was highlighted that it is inherent upon the EIA
Process to undertake a comprehensive and integrated approach in the review and
evaluation of environment-related concerns of government agencies (GAs), local
government units (LGUs) and the general public. The subsequent EIA findings shall
provide guidance and recommendations to these entities as a basis for their decision
making process.44
As such, it must be that whenever a project falls within the purview of the PEISS and
DA AO No. 8, s. 2002, as well as other relevant laws, as Philippine biosafety regulations
now stand and as required by the NBF, the project proponent is required to
comply with all applicable statutory or regulatory requirements, not just DA
AO No. 8, s. 2002.
With these, it is respectfully submitted that the omission by the project proponents of
securing an ECC or CNC, whichever is proper for its project, prior to the conduct of the
field testing, and the DENR-EMB's failure to evaluate GMO field trials within the purview
of the PEISS and simply allowing the trials to be conducted without a prior
determination of whether the conduct of an EIA or the prior securing of an ECC is a
condition sine qua non for its conduct, warrant the issuance of a permanent
environmental protection order directing:
On these premises, I vote to DENY the petition on the grounds that the project
proponents failed to comply with the requirements under the PEISS and that the DENR-
EMB failed to require from/he project proponents the securing of an ECC or a CNC prior
to the field^testing of the Bt talong.
Endnotes:
1
Item 3.3, Section 3, EO 514, s. 2006.
2
Sub-item 3.3.12, Item 3.3, Section 3, EO 514, s. 2006.
3
Sub-item 3.3.2, Item 3.3, Section 3, EO 514, s. 2006.
4
Sub-item 3.3.12, Item 3.3, Section 3, EO 514, s. 2006.
5
Establishing An Environmental Impact Statement System Including Other
Environmental Management Related Measures And For Other Purposes.
6
Philippine Judicial Academy, A Sourcebook on Environmental Rights and Legal
Remedies, p. 58.
7
B. Environmentally Critical Areas
1. All areas declared by law as national parks, watershed reserves, wildlife preserves
and sanctuaries;
3. Areas which constitute the habitat for any endangered or threatened species of
indigenous Philippine Wildlife (flora and fauna);
d. which act as natural buffers against shore erosion, strong winds and storm floods;
12. Coral reefs, characterized by one or any combinations of the following conditions: chanRoblesvirtualLawlibrary
8
A. Environmentally Critical Projects
I. Heavy Industries
d. Smelting plants
b. Forestry projects
1. Logging
4. Forest occupancy
6. Grazing
c. Fishery Projects
a. Major dams
9
Republic v. City of Davao, G.R. No. 148622, September 12, 2002, 388 SCRA 691.
10
Section 4, PD 1586.
11
Sec. 5, PD 1586.
12
Evolution of the Philippine Biosafety System, Department of Agriculture-Bureau of
Plant Industry, http://biotech.da.gov.ph/. Last accessed, December 7, 2015.
13]
http://www.ncbp.dost.gov.ph/19-guidelines/24-executive-order-no-430-s-1990. Last
accessed November 23, 2015.
14
WHEREAS, the impact qf the new technologies on health, agriculture, chemical and
pharmaceutical, and environment and natural resources has been a continuing
worldwide concern of many countries;
WHEREAS, biotechnology ha? high potential to improve the quality of human life may
have concomitant risks and hazards to health Safety, the environment and society;
WHEREAS, the hazards associated with the processes and the products of researches in
biotechnology may be minimized, if hot totally eliminated, by the different containment
levels and procedures observed in the laboratories and greenhouses;
WHEREAS, most of the risks are associated with the field testing and eventual
deliberate release of genetically manipulated/engineered orjganisms into the
environment;
WHEREAS, there is a need to iconstitute a body that shall undertake the study and
evaluation of existing laws, policies and guidelines bn biotechnology and its related
matters, and recommend such measures for its effective utilization and prevention of
possible pernicious effects in the environment. (EO 430, s. 1990)
15
Section 4, EO 430 s. 1990.
16
NCBP Monograph dated May 15, 1998.
17
SECTION 9. REPEALING CLAUSE All provisions of the Philippine Biosafety Guidelines
(1991 edition), particularly Part III, paragraph 2.3 (Field release of Regulated
Materials), which are inconsistent with this Monograph are hereby repealed.
18
p. 15, Biosafety Regulations in the Philippines: A Review of the First fifteen Years,
Preparing for the Next Fifteen, A Report of the National Committee on Biosafety of the
Philippines (NCBP), by the National Academy on Science and Technology (NAST),
Department of Science and Technology (DOST), NCBP, and the Program for Biosafety
Systems (2009).
19
Id.
20
Item A, Section 2, DA AO No. 8, s. 2002.
21
Item B, Section 2, DA AO No. 8, s. 2002.
22
pp. 29-30, Biosafety Regulations in the Philippines: A Review of the First fifteen
Years, Preparing for the Next Fifteen, A Report of the National Committee on Biosafety
of the Philippines (NCBP), by the National Academy on Science and Technology (NAST),
Department of Science and Technology (DOST), NCBP, and the Program for Biosafety
Systems (2009).
23
p. 15, Biosafety Regulations in the Philippines: A Review of the First fifteen Years,
Preparing for the Next Fifteen, A Report of the National Committee on Biosafety of the
Philippines (NCBP), by the National Academy on Science and Technology (NAST),
Department of Science and Technology (DOST), NCBP, and the Program for Biosafety
Systems (2009).
24
WHEREAS, there is a need to enhance the existing biosafety framework to better
respond to the challenges presented by further advances in modern biotechnology and
to comply with the administrative requirements of the Cartagena Protocol on Biosafety.
25
Sub-section 4.2 (Composition of the NCBP), Section 4 (Administrative Framework)
(EO 514).
26
SECTION 4. ADMINISTRATIVE FRAMEWORK. The administrative mechanism for
biosafety decisions shall be as follows:
chanRoblesvirtualLawlibrary
(a) National scientific and technical biosafety standards and standards on methods and
procedures for ensuring biosafety in the country shall be set by the NCBP consistent
with existing laws: Basic policies on addressing public interests on biosafety shall be
developed by the NCBP, provided the same are consistent with law and if such policies
are found insufficiently addressed in existing mandates and regulations of pertinent
agencies;
(b) Member-agencies of the NCBP shall continue to perform their regulatory functions in
accordance with their legal mandates, provided that their policies and programs relating
to biosafety shall be discussed in the NCBP for purposes of harmonization with other
agencies' functions;
(c) Other concerned agencies shall coordinate with NCBP on matters that may affect
biosafety decisions as provided in Sections 4.7 to 4.14;
(d) Administrative functions required under the Cartagena Protocol on Biosafety shall be
performed by agencies as provided in Section 4.14 and 4.15; and,
(e) The role of stakeholders and the general public shall be recognized and taken into
account as provided in Sections 6 and 7. (EO 514)
27
Item 4.8, Section 4 [Administrative Framework], EO 514.
28
Item 4.7, Section 4 [Administrative Framework], EO 514.
29
Item 4.9, Section 4 [Administrative Framework], EO 514.
30
Section 8. Repealing and Amending Clause. All orders, rules and regulations or parts
thereto which are inconsistent with any of the provisions of this Order are hereby
repealed or amended accordingly. For the avoidance of doubt, the following issuances,
unless amended by the respective issuing departments or agencies, shall continue to be
in force and effect: Department of Agriculture Administrative Order No. 008, s. 2002;
the NCBP Guidelines on the Contained Use of Genetically Modified Organisms, except
for provisions on potentially harmful exotic species which are hereby repealed; and all
Bureau of Food and Drugs issuances on products of modern biotechnology.
31
The NCBP reviews proposals on modern biotechnology applications for the benefit of
the final approving bodies (agencies which have regulatory functions on specific areas
such as the Department of Agriculture's Bureau of Plant Industry or the Department of
Health or the Department of Environment and Natural Resources which are official
members of the NCBP). The NCBP's actions of "approval" or "disapproval" of
biotechnology applications is restricted to "research and development, technical aspects
(whether or not, on the basis of existing science, safety risk are considered
acceptable); scientific advice (i.e., it is directed to pertinent line agencies to provide
them a basis for acting on proposed applications; its action ("approved" or
"disapproved") is not a final permission to do the application; its action does not
preclude any other requirements of laws or by line agencies; final permission is to be
granted by appropriate line agencies." [Biosafety Regulations in the Philippines: A
Review of the First fifteen Years, Preparing for the Next Fifteen, A Report of the
National Committee on Biosafety of the Philippines (NCBP), by the National Academy on
Science and Technology (NAST), Department of Science and Technology (DOST), NCBP,
and the Program for Biosafety Systems (2009), p. 15]
32
Role of Environment 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. [Item 5.3, Section 5, EO 514].
33
Item 4.9, Section 4 [Administrative Framework], EO 514.
34
Id.
35
Item 3.3 [Definitions], Section 3 [Scope, Objectives and Definitions], EO 514.
36
See List of Covered Projects of the Philippine E1S System, item (g), Revised
Procedural Manual for DENR AO No. 30 s. 2003 [DAO 03-30].
37
Biosafety Regulations in the Philippines: A Review of the First fifteen Years, Preparing
for the Next Fifteen, A Report of the National Committee on Biosafety of the Philippines
(NCBP), by the National Academy on Science and Technology (NAST), Department of
Science and Technology (DOST), NCBP, and the Program for Biosafety Systems (2009).
38
Principle 15 - In order to protect the environment, the precautionary approach shall
be widely applied by States according to their capabilities. Where there are threats of
serious or irreversible damage, lack of full scientific certainty shall not be used as a
reason for postponing cost-effective measures to prevent environmental degradation.
39
Article 1 [Objective] - In accordance with the precautionary approach contained in
Principle 15 of the Rio Declaration on Environment and Development, the objective of
this Protocol is to contribute to ensuring an adequate level of protection in the field of
the safe transfer, handling and use of living modified organisms resulting from modern
biotechnology that may have adverse effects on the conservation and sustainable use
of biological diversity, taking also into account risks to human health, and specifically
focusing on transboundary movements.
40
6. Lack of scientific certainty due to insufficient relevant scientific information and
knowledge regarding the extent of the potential adverse effects of a living modified
organism on the conservation and sustainable use of biological diversity in the Party of
import, taking also into account risks to human health, shall not prevent that Party
from taking a decision, as appropriate, with regard to the import of the living modified
organism in question as referred to in paragraph 3 above, in order to avoid or minimize
such potential adverse effects.
41
8. Lack of scientific certainty due to insufficient relevant scientific information and
knowledge regarding the extent of the potential adverse effects of a living modified
organism on the conservation and sustainable use of biological diversity in the Party of
import, taking also into account risks to human health, shall not prevent that Party
from taking a decision, as appropriate, with regard'to the import of that living modified
organism intended for direct use as food or feed, or for processing, in order to avoid or
minimize such potential adverse effects.
42
Item 2.6, EO 514.
43
Overview of the Philippine EIS System (PEISS), Revised Procedural Manual for DENR
AO No. 30 s. 2003, p. 3 [DAO 03-30].
44
Id. cralawlawlibrary
CONCURRING OPINION
LEONEN, J.:
The Petition for Writ of Kalikasan of Greenpeace Southeast Asia (Philippines), et al.
(now respondents), insofar as it assails the field testing permit granted to private
petitioners, should have been dismissed and considered moot and academic by the
Court of Appeals. The Petition for Writ of Kalikasan was filed only a few months before
the two-year permit expired and when the field testing activities were already over.
Thus, the pending Petitions which assail the Decision of the Court of Appeals should be
granted principally on this ground. There was grave abuse of discretion which amounts
to excess of jurisdiction.
This does not necessarily mean that petitioners in G.R. No. 209271 can proceed to
commercially propagate Bt talong. Under Department of Agriculture Administrative
Order No. 8, Series of 2002, the proponent should submit a new set of requirements
that will undergo a stringent process of evaluation by the Bureau of Plant Industry and
other agencies. Completion of field testing by itself does not guarantee commercial
propagation.
Application for each stage has its own set of unique requirements. The standards of
review have their own level of rigor. All the applications for each stage should be
published. Public participation in each stage must not only be allowed but should be
meaningful.
The effect of the invalidity of Administrative Order No. 8 is that petitioners cannot
proceed further with any field testing or propagation for lack of administrative
guidelines. Any test or propagation of transgenic crops should await valid regulations
from the executive or restatements of policy by Congress.
Furthermore, the Petitions in this case should be granted because the Court of Appeals,
in adopting the "hot tub" method to arrive at its factual findings, gravely abused its
discretion. The transcript of the proceedings presided by the Court of Appeals Division
shows how this method obfuscated further an already complicated legal issue. Courts of
law have a precise and rigorous method to ferret out the facts of a case, a method
which is governed by our published rules of evidence. By disregarding these rules, the
Court of Appeals acted whimsically, capriciously, and arbitrarily.
This is an important case on a novel issue that affects our food security, which touches
on the controversial political, economic, and scientific issues of the introduction of
genetically modified organisms into the consumer mainstream. This court speaks
unanimously in narrowing down the issues and exercising restraint and deference. This
court must allow the competencies of the administrative regulatory bodies and
Congress to fully and meaningfully evolve.
The cessation of the validity of all the biosafety permits issued to the University of the
Philippines Los Banos in June 2012 and the termination of all field trials as of August
10, 2012 render the Petition for Writ of Kalikasan moot and academic.1 The Petition for
Writ of Kalikasan was originally filed before us on April 26, 2012.2
A brief overview of the regulatory process outlined in Administrative Order No. 8 will
assist us in providing a framework to put the Petition in context.
Administrative Order No. 8 recognizes three (3) stages before genetically modified
organisms—as products, ingredients, or processes— may become commercially
available.
The second stage is Field Testing where regulated articles are intentionally introduced
into the environment in a highly regulated manner also for experimental purposes. It is
specifically recognized that in field testing, no specific physical containment measures
shall be undertaken "to limit that contact of the regulated article with ... the general
population and the environment."4 Prior to field testing, the results of the contained
experiments are taken into consideration.
Each stage is distinct. Subsequent stages can only proceed if the prior stage/s are
completed and clearance is given to engage in the next regulatory stage. This is evident
from the requisites for conducting each stage.
For contained use, the importation or the removal from point of entry of the material
requires (i) authorization given by the Bureau of Plant Industry; and (ii) a letter of
endorsement issued by the National Committee on Biosafety of the Philippines.5 The
National Committee on Biosafety of the Philippines, on the other hand, proceeds with its
own processes for evaluation of the application for contained use.
Field testing requires that "(i) a Permit to Field Test has been secured from the [Bureau
of Plant Industry]; and (ii) the regulated article has been tested under contained
conditions in the Philippines."6
Release for commercial propagation will not be allowed unless "(i) a Permit for
Propagation has been secured from [the Bureau of Plant Industry]; (ii) it can be
shown that based on field testing conducted in the Philippines, the regulated
article will not pose any significant risks to the environment; (iii) food and/or
feed safety studies show that the regulated article will not pose any significant risks to
human and animal health; and (iv) if the regulated article is a pest-protected plant, its
transformation event has been duly registered with the [Fertilizer and Pesticide
Authority]."7
It is, thus, improper to rely on the expectation that commercial propagation of Bt
talong shall ensue after field testing. For the process to proceed to commercial
propagation, the concerned applicants are still required to formally seek the permission
of the Bureau of Plant Industry by filing an application form. There is no presumption
that the Bureau of Plant Industry will favorably rule on any application for commercial
propagation. It is also not a valid presumption that the results of field testing are
always favorable to the proponent for field testing let alone for those who will continue
on to propagation.
The alleged actual controversy in the Petition for Writ of Kalikasan arose out of the
proposal to do field trials. The reliefs in these remedies did not extend far enough to
enjoin the use of the results of the field trials that have been completed. Essentially,
the findings should be the material to provide more rigorous scientific analysis
of the various claims made in relation to Bt talong.
The original Petition was anchored on the broad proposition that respondents' right to a
healthful and balanced ecology was violated on the basis of the grant of the permit.
With the cessation of the validity of the biosafety permits and the actual termination of
all field trials, the very subject of the controversy adverted to by respondents became
moot. Similarly because of the Petition's specificity, the case could not be considered
capable of repetition yet evading review and, thus, an exception to the rule on
mootness.
II
Nevertheless, for the guidance of the bench and bar, the validity of the biosafety
permits is discussed. The biosafety permits should have been declared null and void-
due to the invalidity of Administrative Order No. 8.
The role of the National Committee on Biosafety of the Philippines was further
strengthened in 2006 under Executive Order No. 514, which established the National
Biosafety Framework for the Philippines. The Framework 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."10
A more recent law, Republic Act No. 10068, otherwise known as the Organic Agriculture
Act of 2010, also promotes the use of biotechnology but specifically excludes genetically
modified organisms.13 The law does not provide regulatory standards for genetically
modified organisms.
Aside from the enactment of domestic executive orders and laws, Administrative Order
No. 8 was enacted to comply with the Cartagena Protocol on Biosafety to the
Convention on Biodiversity. The Convention on Biodiversity came into force on
December 29, 1993, and the Cartagena Protocol on Biosafety supplemented the
Convention on Biodiversity by providing policy standards for biosafety in the use of
living modified organisms.14
III
Two constitutional provisions bear upon the issues relied upon by private respondents
in this case. Both are found in Article II, viz.:
Section 15. The State shall protect and promote the right to health of the people and
instill health consciousness among them.
Section 16. The State shall protect and advance the right of the people to a balanced
and healthful ecology in accord with the rhythm and harmony of nature.
Traditionally, these provisions articulate the doctrine that health and ecological
concerns are proper purposes of regulation and, therefore, can be the basis of the
state's exercise of police power.17 Having constitutionally ordained goals and principles
are, per se, compelling state interests.18
Thus, restricting the rights to property and liberties does not deny their holders their
"due process of law" provided there is a discemable rational relationship between the
regulatory measure and these legitimate purposes. We have, prior to the 1987
Constitution, adopted a fairly consistent deferential standard of judicial review
considering that the Congress has more leeway in examining various submissions of a
wider range of experts and has the power to create the forums for democratic
deliberation on various approaches.
The requirement of adopting the least restrictive means requires that respondent
agencies show that there were alternatives considered within the democratic and
deliberative forums mandated by law and that clear standards were considered within
transparent processes. It is not for this court to consider the validity of the standards
chosen. We must, however, be convinced that there is such a standard, that it was
assiduously applied, and the application was consistent.
IV
Sections 15 and 16 of Article II are, thus, not simply hortatory rights. They are as much
a part of the fundamental law as any other provision in the Constitution. They add to
the protection of the right to life in Article III, Section 1.
The right to life is textually broad to signal the intention that the sphere of autonomy is
assumed to encompass life both in terms of its physical integrity and in terms of its
quality.25
cralawred
Sections 15 and 16, however, impose on the state a positive duty to "promote and
protect" the right to health and to "promote and advance" the right of "the people to a
balanced and healthful ecology." With respect to health and ecology, therefore, the
state is constitutionally mandated to provide affirmative protection. The mandate is in
the nature of an active duty rathe.r than a passive prohibition.
In short, the constitutional provisions embed the idea that there is no invisible
hand26 that guides participants in the economic market to move toward optimal social
welfare in its broadest developmental sense.
Producers, by their very nature, participate in the market motivated by their objective
to recover costs and maximize their profits. Costs for them usually refer to their
pecuniary expenditures. Costs suffered incidentally by the ecology of the locations of
their factories or by the health of their consumers are not costs which producers readily
and naturally internalize.27 In an unregulated market, they do not spend their capital to
mitigate or remedy these types of damages.28 In many instances, there is the tendency
even to avoid incurring expenses to find out whether these types of damages actually
occur. Environmental damage and health risks are, thus, externalities which are usually
invisible to them. Externalities are costs which remain unrecognized in the private
transaction between the producers and their consumers.
Of course, producers will respond to both the quantity and quality of demand in a
market. In an unregulated market, collective consumer preferences will define the
types of products that producers will sell. In turn, this will provide the strongest
incentive for producers to specialize their products in an efficient and economical
manner.
Consumers, however, are also shaped by the incentives in the market. The nature of
the benefits which defines incentives is likewise framed by the pervading culture.
Health and consciousness may evolve among consumers. There are, for instance, those
who will definitely purchase organic, nontransgenic, and unadulterated food products as
a matter of personal choice. There will also be those who, like rminy of the private
respondents in this case, evolve movements to convince the consumers to shift their
tastes and their preferences.
Choices of consumers also depend on the consciousness that the present culture
sponsors:
Consciousness can be defined as "the way people conceive of the 'natural' and normal
way of doing things, their habitual patterns of talk and action, and their commonsense
understanding of the world."29 ChanRoblesVirtualawlibrary
Legal consciousness, on the other hand, is simply "all the ideas about the nature,
function and operation of law held by anyone in society at a given time."30 This means
that the culture and framework of defining incentives and making choices among our
consumers also depend on the content .of the law and its interpretation in
administrative regulatory issuances and judicial decisions.
The imperative for the state's more active participation in matters that relate to health
and ecology is more salient given these perspectives and the pervasive impact of food
on our population.
At its bare minimum, Sections 15 and 16 imply that the standard to be used by the
state in the discharge of its regulatory oversight should be clear. This is where
Administrative Order No. 8 fails. While providing for processes, it does not refer to any
standard of evaluating the applications to be presented before the Department of
Agriculture or, in field testing, the Scientific Review Technical Panel. There are many of
such standards available based on best practices. For instance, the regulators may be
required to evaluate applications so that there is a scientific demonstration of a
"reasonable certainty of no harm"31 to both health and environment in all aspects in the
creation, testing, and propagation of genetically modified ingredients, processes, or
products.
In addition to constitutional provisions under Article II, the Philippines also sources its
environmental obligations from conventions and subsequent protocols. On May 24,
2000, the Philippines became one of the signatories to the Cartagena Protocol on
Biosafety to the Convention on Biodiversity.32 By September 11, 2003, the Cartagena
Protocol entered into force in the Philippines.33
The Cartagena Protocol's objective is to ensure "an adequate level of protection in the
field of the safe transfer, handling and use of living modified organisms resulting from
modern biotechnology. . . ."34 Article 23 of the Cartagena Protocol35 stresses that the
public must be consulted in the decision-making process regarding living modified
organisms, and that the decisions made with this regard must be communicated to the
public.36
The Cartagena Protocol emphasizes that risk assessment should be carried out in a
scientifically sound manner.37 In addition, Annex III of the Cartagena Protocol also
provides that risk assessment must also be done in a transparent manner.38
Subsequent executive actions reflect the obligations of the Philippines under the
Cartagena Protocol. Executive Order No. 514, which established the National Biosafety
Framework, was enacted "to comply with the administrative requirements of the
Cartagena Protocol on Biosafety," among other reasons.39 Executive Order No. 514
restructured the National Committee on Biosafety of the Philippines, an interagency,
multisectoral body in charge of the National Biosafety Framework.40
Executive Order No. 514, while not a statute, provides binding policies and rules for the
executive agencies of government in their task of implementing its legal obligations
under the Cartagena Protocol. Hence, all actions of agencies involved in the execution
of biosafety in the Philippines must follow the Cartagena Protocol, the National
Biosafety Framework, and our Constitution.
Like the National Biosafety Framework established by Executive Order No. 514,
Administrative Order No. 8 cites the Cartagena Protocol as a source of obligation of the
state to regulate transgenic plants.43
Administrative Order No. 8 fails to meet certain standards required under the Cartagena
Protocol.
This Order requires an applicant for field testing of a regulated article to create an
Institutional Biosafety Committee. It is the applicant who chooses the members of the
Institutional Biosafety Committee.
In addition, there are other problems with public participation in Administrative Order
No. 8. For field testing under Administrative Order No. 8, the only opportunity for public
participation is under Sections 8(G) and 8(H). Under Section 8(G), the public
consultation on an application is prompted by the posting of the Public Information
Sheet on Field Testing, which shall be posted in three conspicuous places in the
barangay/city/municipality for three consecutive weeks. The interested party is 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 as to simply leave this through the fictional notice of public
posting. The positive duty of the state requires more in terms of the creation of public
awareness and understanding. For instance, the Department of Agriculture is
competent and large enough so as to make actual face to face community meetings
reasonable.
Also, under the National Biosafety Framework, there must be posting on the Internet to
capture the attention of relevant stakeholders.46 This is not required under Section
8(G).
The mechanism under Administrative Order No. 8 does not even require that local
government authorities be apprised about the proposed field testing. Certainly,
engaging local government authorities invites more meaningful public discourse.
Section 8(H) requires the creation of a Scientific and Technical Review Panel. This is a
group of three independent scientists that reviews the risk assessment conducted by
the Institutional Biosafety Committee. The Scientific and Technical Review Panel does
not have a community representative. It is also tasked to evaluate—based on the
individual scientist's own standards—whether the proposed field testing poses
significant risks on 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 Administrative Order No. 8. In this regard, there is no
standard or process.
The nonchalant attitude of the regulatory framework is best seen in this case.
Petitioners alleged that there was some public consultation prior to field testing. These
consultations, however, were not documented. The only proof of such consultation was
a bare allegation made by Miss Merle Palacpac of the Department of Agriculture in her
judicial affidavit.47
The absence of an effective mechanism for public feedback during the application
process for field testing means that Administrative Order No. 8 fails in meeting the
public participation requirement of the Cartagena Protocol and the National Biosafety
Framework. The current mechanisms have all the badges of a "greenwash":48 merely an
exhibition of symbolic compliance to environmental and biosafety policy.
VI
Due to these fundamental deficiencies, Administrative Order No. 8 is null and void. In
its present form, it cannot be used as the guidelines to regulate further field testing or
commercial propagation of Bt talong. Until a law or a new regulation is passed
consistent with the Constitution, our treaty obligations, and our laws, no genetically
modified ingredient process or product can be alloVved to be imported, field tested, or
commercially propagated.
VII
Science is not just a body of knowledge; it is the result of the application of the
scientific methodology.49 The direction of the methodology depends on the objective of
each study or research. The scientific methodology tests a hypothesis, or a proposed
statement of relationships between factors or variables that acts as a tentative answer
to a specific research question.50
From the hypothesis, a scientist reviews related literature and records observations
relating to the hypothesis. Sampling, observations, and measurements must
be accurate and replicable. These areas are vulnerable to errors that may distort a
research's conclusions.51 In order to confirm found observations, a scientist can design
tests in order to make observations under controlled conditions.52
This basic process is also found in the environmental risk assessments conducted for
transgenic crops. There are four important steps in Environmental Risk Assessments: chanRoblesvirtualLawlibrary
(1) Initial evaluation - This step determines whether risk assessment is required.
(2) Problem formulation - This step involves the formulation of risk hypothesis to be
tested in the laboratory and field. An example of a risk hypothesis is whether the
transgenic crop affects nontargeted organisms.
(3) Controlled experiment and gathering information - These are done first in the
laboratory, and then under controlled field conditions.
The results of scientific experimentation with transgenic crops form part of science.
However, these research articles must be rigorously and deliberately examined to
scrutinize their subject matter, the hypothesis and methodology deployed, and the
cogency of the conclusions drawn from the observed findings.
Certainly, the conclusions in studies concerning Bt maize may not always be valid with
respect to Bt talong. Some of the variables may be the same. Obviously, both
transgenic crops include the vector bacillus thuringiensis. However, there will also be
obvious differences because of the difference of the crops, their behavior in various
environments, the manner in which-they reproduce, their uses, and their
consequences.
Currently, there is more literature regarding the viability and safety of Bt maize
because it is already being commercially propagated. On the other hand, Bt talong is
still being studied and assessed and is not yet ready for commercial release. The
application for field testing for Bt talong under the correct conditions is itself part of the
scientific inquiry to test hypotheses both for or against its propagation.
The Court of Appeals, instead of relying on these standards of science, employed a "hot
tub" examination of experts. It took into account literature on Bt maize or Bt cotton,
and various arguments and studies conducted for Bt maize. It then made conclusions,
without a rigorous explanation of its methodology and standards for credibility, from
these studies.
Without these rigorous explanations, the Court of Appeals committed grave abuse of
discretion when it considered Bt maize research. Ideally, the Court of Appeals should
have scrutinized the results of the contained experimentation with respect to Bt
talong because the results were the basis for the Bureau of Plant Industry's allowance
of field testing.54 It should have examined whether the experimentation conducted may
be replicated and whether it will yield the same result.
The experts could have also been asked individually about the results of contained
experimentation and if the contained experiments answered research objectives
relating not only to the viability of the product, but the impact to the environment
should the product undergo field testing. The first objective is in line with the
commercial interests of the applicant, while the latter objective is more in tune with the
state's policy of protecting the right of the people to a balanced and healthful ecology.
The imposition of the latter objective should* have been the role of the Bureau of Plant
Industry because it was the authorizing agency for field testing permits.
The Court of Appeals committed grave abuse of discretion by relying only on the study
of Dr. Gilles-Eric Seralini who made a study involving a completely different transgenic
crop. This court tasked the Court of Appeals to assess the propriety of the issuance of
field testing permits with respect to Bt talong, not to draw conclusions about Bt
talong based on one scientific literature on Bt maize.
The results of the field testing of Bt talong should still be subject to confirmatory tests
involving the same variables in order to attain a level of statistical reliability. However,
these subsequent field testing must be done under regulations consistent with our
Constitution and international obligations. They must be conducted under a regulatory
agency that will have the competence to be actively involved in the scientific inquiry.
VIII
The results of this case are neither an endorsement nor a repudiation of genetically
modified ingredients, processes, and food products. This should neither be interpreted
as a rebuke of the avowed mandates of respondents, many of whom have distinguished
themselves in their advocacies.
Certainly, there is a need for leaders, organizations, and dedicated movements that
amplify the concerns of communities, groups, and identities which tend to be put in the
margins of forums dominated by larger and more politically connected commercial
interests. This includes forums that create and implement regulatory frameworks.
Liberal democratic deliberations at times fail to represent the silenced majority as it
succumbs to the powerful minority.
While acknowledging this reality, we also need to be careful that the chambers of this
court do not substitute for the needed political debate on public issues or the analytical
rigor required by truths in science. We are Justices primarily. While politics and science
envelope some of our important decisions, we should not lose the humility that the
Constitution itself requires of us. We are an important part of the constitutional order:
always only a part, never one that should dominate. Our decisions have the veneer of
finality. It should never, however, be disguised superiority in any form or manner.
Political debates indeed also mature when we pronounce the nature of fundamental
rights in concrete cases. Before cases ripen—or, as in this case, when it has become
moot—restraint will be the better approach. We participate in the shaping of the
content of these fundamental rights only with the guidance of an actual case. This,
among others, distinguishes the judicial function from the purely political engagement.
Restraint is especially required when the remedy chosen is a Petition for the issuance of
a Writ of Kalikasan, which is designed to prevent an actual or imminent environmental
catastrophe. Again, in this case, the field testing ended. There is yet no permit to
commercially propagate Bt talong. The results of the field testing of the genetically
modified food crop have not been presented for evaluation by any of the relevant
agencies charged with its eventual regulation. Moreover, the results of the field testing
have not been presented for proper public scrutiny.
If any, the resolution of this case implies rigor in environmental advocacy. Vigilance and
passion are the hallmarks of the public interest movement. There is no reason that the
members of this movement should not evolve the proper skills and attitudes to properly
work the legal system and understand the role of the judicial process. Environmental
advocacy also requires an understanding of science and the locating of the proper place
of various norms such as the precautionary principle. After all, representation of
marginalized community voices deserves excellent representation and responsible
leadership. Filing a judicial remedy almost two years too late and without the required
scientific rigor patently required by the allegations and the arguments misses these
standards.
But, we cannot "just leave things as they are especially when patent unconstitutional
provisions surface and where deference will amount to a denial of the positive
constitutional duties we are required to discharge. There are grave errors in
Administrative Order No. 8 that stack decisions made by the Department of Agriculture
and the Bureau of Plant Industry in favor of the commercial applicant. We have so far
only evaluated the provisions in accordance with law and found them wanting. By
declaring Administrative Order No. 8 null and void, there is now incentive for either
Congress or our administrative bodies to review the present regulatory framework and
bring it not only to legal fiat but also to address all concerns including those voiced by
respondents in this case.
Food safety and food security are vital for the assurance of human dignity. We can only
hope that the complex issues relating to genetic modification of the food we eat be
debated deliberately, vigorously, and with all the scientific rigor and rationality required
in the proper public forums. Food safety and food security are complex issues requiring
the benefit of all the wisdom of all our people.
Endnotes:
1
Ponencia, p. 41.
2
Id. at 11.
3
DA Adm. Order No. 8 (2002), sec. 1(E): chanRoblesvirtualLawlibrary
E. "Contained Use" means the use of a regulated article for research and development
inside a physical containment facility intended to limit its contact with, and to provide
for a high level of safety for, the general population and the environment and which has
been inspected and approved by NCBP.
4
DA Adm. Order No. 8 (2002), sec. 1(I): chanRoblesvirtualLawlibrary
I. "Field testing" means any intentional introduction into the environment of a regulated
article for purposes of research and development and for which no specific physical
containment measures are used to limit the contact of the regulated article with, and to
provide for a high level of safety for, the general population and the environment. Field
testing may be conducted in a single site or in multiple sites.
5
DA Adm. Order No. 8 (2002), sec. 6.
6
DA Adm. Order No. 8 (2002), sec. 7.
7
DA Adm. Order No. 8 (2002), sec. 9.
8
DA Adm. Order No. 8 (2002), first Whereas clause.
9
Exec. Order No. 430 (1990), otherwise known as Constituting the National Committee
on Biosafety of the Philippines (NCBP) and for Other Purposes.
10
Exec. Order No. 514, sec. 2.1.
11
Rep. Act No. 8435, sec. 3(a).
12
Rep. Act No. 8435, sec. 111(5).
13
Rep. Act No. 10068, sec. 3(b) Organic agriculture includes all agricultural systems
that promote the ecologically sound, socially acceptable, economically viable and
technically feasible production of food and fibers. Organic agriculture dramatically
reduces external inputs by refraining from the use of chemical fertilizers, pesticides and
Pharmaceuticals. It also covers areas such as, but not limited to, soil fertility
management, varietal breeding and selection under chemical and pesticide-free
conditions, the use of biotechnology and other cultural practices that are consistent
with the principles and policies of this Act, and enhance productivity without destroying
the soil and harming farmers, consumers and the environment as defined by the
International Federation of Organic Agriculture Movement (IFOAM); Provided, That the
biotechnology herein referred to shall not include genetically modified
organisms or GMOs. (Emphasis supplied)
14
Cartagena Protocol on Biosafety to the Convention on Biological Diversity
<https://www.cbd.int/doc/legal/cartagena-protocol-en.pdf> (visited December 1,
2015).
15
DA Adm. Order No. 8 (2002), sixth Whereas clause.
16
Defined in DA Adm. Order No. 8 (2002), sec. 1(N).
17
See Laguna Lake Development Authority v. Court of Appeals, G.R. No. 110120, March
16, 1994, 231 SCRA 292, 307-308 [Per J. Romero, Third Division].
18
See for example Diocese of Bacolod v. COMELEC, G.R. No. 205728, January 21, 2015
<http://sc.judiciary.gov.ph/pdf/web/viewer.html?
file=/jurisprudence/2015/january2015/205728.pdf> 50 [Per J. Leonen, En
Banc], citing CONST., art. II, secs. 12 and 13; Soriano v. Laguardia, et al., 605 Phil.
43, 106 (2009) [Per J. Velasco, Jr., En Banc]. In Diocese of Bacolod, we stated:
"Compelling governmental interest would include constitutionally declared principles.
We have held, for example, that 'the welfare of children and the State's mandate to
protect and care for them, as parens patriae, constitute a substantial and compelling
government interest in regulating . . . utterances in TV broadcast.'"
19
601 Phil. 245 (2009) [Per J. Austria-Martinez, En Banc].
20
Id. at 282-283.
21
529 Phil. 110 (2006) [Per J. Puno, En Banc].
22
G.R. No. 205728, January 21, 2015, 50 [Per J. Leonen, En Banc].
23
G.R. No. 208062, April 7, 2015 <http://sc.judiciary.gov.ph/pdf/web/viewer.html?
file=/jurisprudcnce/2015/april2015/208062.pdf>[Per J. Leonen, En Banc].
24
See City of Manila v. Laguio, Jr., G.R. No. 118127, April 12, 2005, 455 SCRA 308 [Per.
J. Tinga, En Banc]; White Light Corp. v. City of Manila, 596 Phil. 444 (2009) [Per J.
Tinga, En Banc].
25
See Dissenting Opinion of J. Leonen in Spouses Imbong v. Ochoa, Jr., G.R. Nos.
204819, 204934, 204957, 204988, 205003, 205043, 205138, 205478, 205491,
205720, 206355, 207111, 207172, and 207563, April 8, 2014, 721 SCRA 146, 731-847
[Per J. Mendoza, En Banc] discussing that: chanRoblesvirtualLawlibrary
"The constitutional right to life has many dimensions. Apart from the protection against
harm to one's corporeal existence, it can also mean the "right to be left alone". The
right to life also congeals the autonomy of an individual to provide meaning to his or
her life. In a sense, it allows him or her sufficient space to determine quality of life. A
law that mandates informed choice and proper access for reproductive health
technologies should not be presumed to be a threat to the right to life. It is an
affirmative guarantee to assure the protection of human rights."
26
See ADAM SMITH, THE WEALTH OF NATIONS (1776).
27
JOSEPH E. STIGLITZ, ECONOMICS OF THE PUBLIC SECTOR 215 (2000).
28
Id. at 223.
29
DAVID M. ENGEL, How Does Law Matter in the Constitution of Legal Consciousness?
in HOW DOES LAW MATTER 112 (1998), citing SALLY ENGLE MERRY, GETTING JUSTICE
AND GETTING EVEN: LEGAL CONSCIOUSNESS AMONG WORKING CLASS AMERICANS 5
(1990).
30
Id., citing David Trubek, Where the Action Is: Critical Legal Studies and Empiricism,
36 STAN. L. Rev. 575, 592. He, however, refers to Sarat who "hastens to explain that
he rejects the approach of 'radical Individualization,' that he studies consciousness
rather than attitudes because the latter inappropriately presents 'a picture of persons
influenced by a variety of factors, thinking, choosing, deciding autonomously how and
what to think.'"
31
The United States' Federal Food, Drug, and Cosmetics Act initially coined the
standard "reasonable certainty of no harm" with respect to food safety
evaluations. See Daryl M. Freedman, Reasonable Certainty of No Harm: Reviving the
Safety Standard for Food Additives, Color Additives, and Animal Drugs, 7 ECOLOGY L.Q.
(1978). <http://scholarship.law.berkeley.edu/elq/vol7/iss2/2> (Last Visited: December
1, 2015). The Food and Agriculture Organization of the United Nations reiterated this
standard in their GMO Food Safety Assessment: Tool For Trainers, p. 8.
<http://www.fao.org/3/a-i0110e.pdf> (Last Visited: December 1, 2015).
32
Parties to the Protocol and signature and ratification of the Supplementary
Protocol <https://bch.cbd.int/protocol/parties/> (visited December 1, 2015).
33
Preambular clause in Exec. Order No. 514 (2006).
34
Cartagena Protocol on Biosafety to the Convention on Biological Diversity
<https://www.cbd.int/doc/legal/cartagena-protocol-en.pdf> (visited December 1,
2015).
35
Cartagena Protocol, art. 23. PUBLIC AWARENESS AND PARTICIPATION. 1. The Parties
shall: (a) Promote and facilitate puJfiic awareness, education and participation
concerning the safe transfer, handling and use of living modified organisms in relation
to the conservation and sustainable use of biological diversity, taking also into account
risks to human health. In doing so, the Parties shall cooperate, as appropriate, with
other States and international bodies; (b) Endeavour to ensure that public awareness
and education encompass access to information on living modified organisms identified
in accordance with this Protocol that may be imported.
2. The Parties shall, in accordance with their respective laws and regulations, consult
the public in the decision-making process regarding living modified organisms and shall
make the results of such decisions available to the public, while respecting confidential
information in accordance with Article 21.
3. Each Party shall endeavour to inform its public about the means of public access to
the Biosafety Clearing-House.
36
Cartagena Protocol, art. 23.2.
37
Cartagena Protocol, art. 15.1. Risk assessments undertaken pursuant to this Protocol
shall be carried out in a scientifically sound manner, in accordance with Annex III and
taking into account recognized risk assessment techniques. Such risk assessments shall
be based, at a minimum, on information provided in accordance with Article 8 and other
available scientific evidence in order to identify and evaluate the possible adverse
effects of living modified organisms on the conservation and sustainable use of
biological diversity, taking also into account risks to human health.
38
Cartagena Protocol, Annex III(3).
39
Exec. Order No. 514, Whereas clause.
40
Exec. Order No. 514, sec. 4.1.
41
Exec. Order No. 514, sec. 6. ACCESS TO INFORMATION.
The right of the public and the relevant stakeholders to information related to biosafety
decisions is recognized and shall always be respected in accordance with guidelines to
be issued by the NCBP, which shall include, among others, the following: chanRoblesvirtualLawlibrary
6.3 Information on Biosafety Decisions. The public and stakeholders shall have access
to all biosafety decisions and the information on which they are based, subject to
limitations set in Section 6.2 of this Framework. Such decisions shall summarize the
application, the results of the risk assessment, and other relevant assessments done,
the public participation process followed, and the basis for approval or denial of the
application.
42
Exec. Order No. 514, sec. 7. PUBLIC PARTICIPATION
7.1 Scope of Public Participation. Public participation shall apply to all stages of the
biosafety decision-making process from the time the application is received. For
applications on biotechnology activities related to research and development, limited
primarily for contained use, notice of the filing of such application with the NCBP shall
be sufficient, unless the NCBP deems that public interest and welfare requires
otherwise.
7.2.2 Adequate and reasonable time frames for public participation procedures. Such
procedures should allow relevant stakeholders to understand and analyze the benefits
and risks, consult with independent experts, and make timely interventions. Concerned
departments and agencies shall include in their appropriate rules and regulations
specific time frames for their respective public participation processes, including setting
a minimum time frame as may be appropriate;
7.2.3 Public consultations, as a way to secure wide input into the decisions that are to
be made. These could include formal hearings in certain cases, or solicitation of public
comments, particularly where there is public controversy about the proposed activities.
Public consultations shall encourage exchanges of information between applicants and
the public before the application is acted upon. Dialogue and consensus-building among
all stakeholders shall be encouraged. Concerned departments and agencies shall specify
in their appropriate rules and regulations the stages when public consultations are
appropriate, the specific time frames for such consultations, and the circumstances
when formal hearings will be required, including guidelines to ensure orderly
proceedings. The networks of agricultural and fisheries councils, indigenous peoples and
community-based organizations in affected areas shall be utilized;
7.2.4 Written submissions. Procedures for public participation shall include mechanisms
that allow public participation in writing or through public hearings, as appropriate, and
which allow the submission of any positions, comments, information, analyses or
opinions. Concerned departments and agencies shall include in their appropriate rules
and regulations the stages when and the process to be followed for submitting written
comments; and,
43
DA Adm. Order No. 8 (2002), Whereas clause.
44
DA Adm. Order No. 8 (2002), sec. 1(L).
45
DA Adm. Order No. 8 (2002), sec. 1(L).
46
Exec. Order No. 514, sec. 7.2.1.
47
Judicial Affidavit of Merle Bautista Palacpac dated Feb. 4, 2013, pp. 16-17, par. 56.
48
The term is often used in reference to businesses and corporations that mislead
consumers about the business' environmental performance or the environmental
benefits of a product. Magali A. Delmas and Vanessa Cuerel Burbano, The Drivers of
Greenwashing <http://www.ioe.ucla.edu/media/files/Delmas-Burbano-CMR-2011-gd-
ldh.pdf> (visited December 1, 2015).
49
Mother and Child Health: Research Methods, Chapter 1: Scientific Method 1
<http://www.oxfordjournals.org/our_journals/tropej/online/cechl.pdf> (visited
December 1, 2015).
50
Id. at 3.
51
Id. at 4.
52
Id. at 6.
53
Detlef Bartsch, et al., Field Testing of Transgenic Plants in PLANT BIOTECHNOLOGY
AND GENETICS, PRINCIPLES, TECHNIQUES, AND APPLICATIONS 313 (2008).
54
Petition of Environmental Management Bureau, et al., Annex "E".