Tuesday, December 13, 2016

The trial of Bt talong field trials

The Philippine government issued a policy statement in July 2001 promoting the judicious use of modern biotechnology and its products for food security, equitable access to health services, sustainable and safe environment, and industry development.  In April 2002, rules and regulations on the importation and release into the environment of biotech plants and products were issued.  Department of Agriculture Administrative Order No. 8 (DA AO8), series of 2002 served as the regulatory guidelines in assessing health and environmental safety of biotech crops.

Soon after the approval of the government on the planting of the first biotech crop in December 2002, the agricultural landscape in the Philippines changed significantly, particularly in the corn sector.  From the initial plantings in 2003 of biotech corn in about 20,000 hectares, commercial plantings now cover an area of about 800 thousand hectares, planted by more than 350 thousand farmers. Because of the fast and wide adoption of biotech corn, the country has achieved sufficiency in the supply of yellow corn starting in 2012.

Early traits of biotech corn provide solution to infestation of Asiatic corn borer and problem in maintaining crop stand with the application of herbicides.  Biotech corn available now in the market has the combination of both traits. Biotech corn products in the pipeline have traits that can address other pests and diseases, improving nutritional value, and can withstand harsh climate conditions such as drought.

Bt talong research and development

With the success in the adoption of biotech corn in the country, the Institute of Plant Breeding at the University of the Philippines Los Baños (IPB-UPLB) spearheaded the development of a biotech eggplant that provides resistance to its chronic pest, the fruit and shoot borer.  Eggplant production provides an important source of cash income for small and resource-poor farmers in the country, and accounts for more than 30% of the volume of vegetable production. 

The eggplant fruit and shoot borer (EFSB) is a lepidopterous insect whose larva consumes the inner part of the eggplant fruit.  Damage caused by the EFSB normally results to nearly 80% of yield loss especially during high incidence of infestation.  The pest’s gut, similar to that of the corn borer, is affected by the toxin produced by the cry1a gene. Hence, similar to the first commercialized biotech corn, Bt talong use the gene from the soil borne bacteria Bacillus thuringensis to control EFSB. 

Research started in 2003 in the laboratory and contained experiment was from 2007 to 2009 under the supervision of the National Biosafety Committee of the Philippines (NCBP).  Field trials in Laguna, Pangasinan, Camarines Sur, and North Cotabato were conducted from 2010 to 2012.  Bt talong varieties developed by IPB-UPLB contained a transformation event developed by Mahyco in India and introgressed into local open-pollinated varieties through backcrossing.  The biotech eggplant is the first public-sector initiated research and the first biotech food crop developed in the Philippines.

As with other biotech crops developed in the Philippines and elsewhere, Bt talong followed a rigorous regulatory guidelines and review throughout its research and development process. Research activities on Bt talong followed the strict regulatory requirements stipulated in the Philippine Biosafety Guidelines and the DA AO8 designed to minimize and manage the risks to both human health and to the environment of biotech products produced through modern biotechnology.

Bt talong court trial

The development of Bt talong has never been without any challenges.  For instance, field trial at UP Mindanao in Davao City had to be prematurely terminated in December 2010 because of the anti-biotech stance of the city government and its officials.  At the height of the field trial being conducted at the experimental farm of UPLB, members of Greenpeace Southeast Asia (Philippines) vandalized and uprooted eggplants in February 2011.

In April 2012, Greenpeace Southeast Asia (Philippines), Magsasaka at Syentipiko sa Pagpapaunlad ng Agrikultura (Masipag), and other personalities filed a writ of kalikasan and writ of continuing mandamus in the Supreme Court (SC) to stop the field trials of Bt talong.  The writ of kalikasan is a legal remedy under Philippine law that provides for the protection of one’s rights to “a balanced and healthful ecology in accord with the rhythm and harmony of nature”. Petitioners argued that the field trials of Bt talong violated the constitutional rights of the people to a balanced and healthful ecology pointing out the inherent and potential risks on human and animal health and the environment through “field trial contamination”.

Respondents to the case were Environmental Management Bureau (EMB), Bureau of Plant Industry (BPI), Fertilizer and Pesticide Authority (FPA), UP Los Baños Foundation, Inc. (UPLBFI) and the International Service for the Acquisition of Agri-biotech Applications (ISAAA).

The Supreme Court issued the writ of kalikasan on May 2, 2012 directing the respondents to answer the petition of the anti-biotech entities.  The case was subsequently remanded by the SC to the Court of Appeals (CA) on July 10, 2012 for hearings, reception of evidence, and rendition of judgment.  On October 12, 2012, the appellate court issued a resolution acknowledging the legal standing of the petitioners, non-mootness of the case, and presence of justiciable controversies in relation to non-compliance with environmental and local government laws.  Petitioners maintained that the conduct of Bt talong field trials should be covered by the environmental impact statement (EIS) system and that there were no genuine public consultations conducted in communities within the trial sites prior to the approval of the field trials.

Respondents maintained that since the field trials had already been terminated, petition for writ of kalikasan should be dismissed for being moot and academic.  Moreover, Bt talong field trials do not cause environmental damage and do not prejudice the life, health and property of individuals.

In a span of nearly seven months, hearings on the scientific and factual questions involved were conducted, with both local and foreign experts presenting their arguments and evidence on the case at bar.  The CA adopted the “hot-tub” method in hearing the testimonies and arguments of expert witnesses from both parties.

In a 26-page decision issued on May 17, 2013, the appellate court ruled that “the field trials of genetically modified organisms Bt talong could not be declared as safe to human health and to our ecology with full scientific certainty, being an alteration of an otherwise natural state of affairs in our ecology”.  The court maintained that there is still no full scientific certainty on the effects of the Bt talong to the environment and to the health of the people.  The CA further stressed that the “overall safety guarantee of Bt talong remains unknown”.  This is where the premise of precautionary principle was applied. 

The court also claimed that the existing biosafety regulations issued by the Department of Agriculture (DA) and the Department of Science and Technology (DOST) are insufficient to guarantee the safety of the environment and health of the people.  The appellate court ordered to permanently cease and desist from further conducting Bt talong field trials and protect, preserve, rehabilitate and restore the environment in accordance with the judgment.

Greenpeace and Masipag were quick to commend the decision of the CA and claimed the ruling as “victory to the Filipino people”.  However, farmers felt otherwise.  In a series of public dialogues conducted by the Southeast Asian Regional Center for Graduate Study and Research in Agriculture – Biotechnology Information Center (SEARCA BIC) on Bt talong participated in by key agriculture stakeholders from Pangasinan, Camarines Sur, Isabela, Laguna, Batangas, and Quezon provinces, farmers lamented the undue ruling against Bt talong field trials as a major setback to adopting a much needed technology that is economically beneficial and safe to their health and the environment.  Farmers even signed a manifesto supporting commercial use of biotech crops in the country and asked for the early release of the Bt talong in the market.

A consolidated petition was lodged to the SC to seek reversal of the May 17, 2013 decision and the September 20, 2013 resolution of the appellate court denying the motions for reconsideration filed by Bt talong proponents.  On December 8, 2015, after the review of the petitions and submissions, the SC en banc upheld the decision of the appellate court and further modified the CA ruling. The DA AO8 was nullified which temporarily halted the application for contained use, field testing, propagation and commercialization, and importation of genetically modified organisms until a new administrative order is promulgated in accordance with law.

Members of the scientific community, including student organizations and professional groups whose memberships are composed of well-known scientists such as the National Academy of Science and Technology (NAST), criticized the High Court’s ruling which apparently relied on discredited scientific research and literatures and improperly applied the precautionary principle to support its judgment.  Other stakeholders lamented on the possible negative repercussions of the SC decision on modern biotechnology and scientific advancement in the country.  Some farmer groups had urged the SC to junk the writ of kalikasan against Bt talong and the temporary ban on the commercial use, propagation and importation of other biotech plant products. 

In his concurring opinion to the SC ruling, Justice Marvic M.V.F. Leonen opined that the petition for the writ of kalikasan should have been dismissed and considered moot and academic by the appellate court considering the expiration of the validity of the biosafety permits for the field trials and the actual termination of all the field trials.  Further, Justice Leonen noted “grave abuse of discretion which amounts to excess of jurisdiction” in relation to the CA ruling.

Despite the negative decision of the SC, some positive outcomes were realized with the court’s ruling.  The SC ruling heightened public awareness and interest on modern biotechnology and biotech plant products.  The SC decision had become the topic of discussion for weeks in both mainstream and social media and public dialogues.  A collective voice of scientists defended the science behind the Bt technology and the safety and benefits of biotech crops.  The science community ventilated concerns on the consequences of the SC decision on the advancement of science and technology in the country.  In a demonstration of cooperation and mutual interest, five government agencies worked together to draft and finalize a new directive that would later become the regulatory framework for safety decisions on biotech plant products that is more transparent, participatory, comprehensive, and with strict adherence to high standards of risk assessment.

Supreme Court reversed previous ruling

Undeterred by the decision of the SC, motions for reconsideration were filed by the Bt talong proponents.  An unexpected turn of events occurred on July 26, 2016 when the SC en banc unanimous reversed its previous ruling.  The SC ruled in favor of the Bt talong proponents affirming mootness of the case.  The SC decision further stated that since no commercial propagation of Bt talong took place and research activities never went beyond the field trial phase, “any future threat to the public to a healthful and balanced ecology is more imagined than real.”

The court further noted that it should not have invalidated DA AO8 as it was only “collaterally challenged” and the anti-Bt talong petitioners were merely asking for amendments to the administrative order. The court declared DA AO8 null and void in its previous decision for failure to comply with the provisions of the National Biosafety Framework (NBF).  Three main issues raised by the court in the nullification of DA AO8 were the lack of meaningful public participation on biosafety decisions, non-implementation of the EIS system, and lack of standards for risk assessment.

New regulatory guidelines

The SC ruling in December 2015 required the issuance of new regulatory guidelines for safety assessment of biotech plant products.  Following the order of the SC, the NCBP initiated the drafting, public consultations, and finalization of the Joint Department Circular No. 1 (JDC), series of 2016.   The new regulatory framework became effective on April 15, 2016 replacing the voided DA AO8.  Under the JDC, five relevant government agencies, namely Department of Agriculture (DA), Department of Science and Technology (DOST), Department of Environment and Natural Resources (DENR), Department of Health (DOH), and Department of Interior and Local Government (DILG) participate in the biosafety decision-making process involving the research, development, handling and use, transboundary movement, release into the environment, and management of biotech plant and plant products.  The JDC provides a more rigorous scrutiny of biotech plant products with the inclusion in the safety assessment of environmental impacts, health impacts, and involvement and meaningful participation of the general public and communities in the decision-making process.

The next step

With the field trials of Bt talong already completed, confirming the efficacy of the technology against the fruit and shoot borer and its safety towards beneficial and non-target insects, and with the unanimous ruling of the SC reversing its earlier decision against field tests, immediate commercial release should be considered by its developer.  Farmers are set to gain from the adoption of Bt talong with significant reduction in yield loss, lesser use of pesticides, and increased income.  Consumers are expected to benefit from pesticide-free eggplants that will be made available in the market.

Written by Panfilo G. de Guzman, Associate Scientist of the International Service for the Acquisition of the Agri-biotech Applications. This article was originally published in BIOLIFE Magazine. 

Photos from iStock.