Philippine Biosafety Regulatory Gaps and Initiatives

Philippine Biosafety Regulatory Gaps and Initiatives

Published: 2020.11.23
Accepted: 2020.11.19
309
Science Research Specialist I
Socio-Economics Research Division (SERD), Philippine Council for Agriculture, Aquatic and Natural Resources Research Development

ABSTRACT

The Philippine Biosafety Regulations started out strong in biotechnology and leads the Southeast Asian Region. However, regulatory issues and concerns surfaced that slowed down the progress of the country. Initiatives are currently being done to answer and bridge the gaps. There is a need to establish a liability and redress mechanism to address potential damage from genetically modified organisms (GMOs). However, ratification to the Nagoya-Kuala Lumpur Supplementary Protocol on Liability and Redress is yet to be considered as the Philippines still lacks the capacity to implement such the Supplementary Protocol. The proposed change in language of the inclusion of socio-economic considerations (SECs) from “shall take into account” into “may take into account” aligns the regulation with the language in the Cartagena Protocol on Biosafety, while also limiting the possibility of politicization which is experienced in countries with regulation shaped by SECs. Finally, the emergence of New Breeding Techniques allowed the regulation to be product-based, as compared to the previous process-based regulation of genetic engineering products. Further steps in regulatory reform should then be sensitive to scientific development, while also aiming for international regulatory harmonization. The initiatives will be important as the Philippines prepare for future biotechnology developments.

Keywords: liability and redress, socio-economic considerations (SECs), New Breeding Techniques (NBTs)

INTRODUCTION

The development of biosafety guidelines was prompted by the discovery and use of recombinant DNA (rDNA) technology in biotechnology research in the early 1970s in recognition of their potential hazards to the human health and the environment. The first set of biosafety guidelines was crafted and used for self-regulation of rDNA biotechnology researches at the University of the Philippines Los Baños (UPLB) and the International Rice Research Institute (IRRI). As the use of rDNA biotech spreads to the national research network, the scientists prepared a proposal to establish the National Committee on Biosafety of the Philippines (NCBP) in 1990 through Executive Order 430. The NCBP formulated and published the Philippine Biosafety Guidelines Series 1 in 1991. Since then, NCBP has been serving as the national authority as regards the development of biosafety policies and guidelines in coordination with the concerned agencies and department, for activities involving modern biotechnology and genetically modified organisms (GMOs) (NAST, 2009). The Philippines has also ratified the Cartagena Protocol on Biosafety (CPB), which requires the regulation of GMOs before they are subject to transboundary movements.   

A science-based regulation permitted the Philippines to be the first in Asia to have a GM crop commercialized in 2002—the Bt Corn. By 2006, the spread of cultivation enabled the country to join the ranks of biotech mega-countries (growing at least 50,000 hectares as reported by ISAAA 2016). To this date, the Philippines leads in Southeast Asia in GM crop cultivation. While the country had a strong start in GM research and production, progress has been evidently slower during the last decade especially with the shift in the biosafety policy from the Department of Agriculture Administrative Order no. 8 (DA-AO8) to the Joint Department Circular no. 1 (JDC-1) in 2016. This was the aftermath of a dispute over Bt Eggplant wherein local and internationally backed anti-GMO groups vandalized the field trials. The gap year in 2015 while the AO8 was under review suspended all ongoing and approved applications and forced them to resubmit under the new system of the JDC-1 (USDA-FAS 2020). Constraints in the regulatory process delayed the development of Bt Eggplant despite being on the brink of commercialization. As the national governments were busy with reforming DA-AO8 and crafting JDC-1, such has actually diverted their attention from other pressing issues such as the potential damage from GMOs, new breeding techniques, and socio-economic considerations. 

  The Cartagena Protocol opened the negotiations for establishing a legally binding international instrument for liability and redress, addressing potential damage from the transboundary movement of GMOs. However, the Philippines has not made any move on the international instrument, even if the country is one of the negotiators. Considering that damage may arise from the use of counterfeit seeds, which can be described as the unauthorized production and sale of GM corn seeds, there might be a need to consider ratifying the international instrument.

Another concern is whether the products of New Breeding Techniques (NBTs) will be subject to regulation. NBTs are emerging technologies with wide applications in agricultural research, and the existing regulatory systems (not just in the Philippines but also in many other countries). Through SDN1 and SDN2 of NBTs, it is possible to develop genetically edited plant varieties that do not possess a foreign gene. By virtue of the absence of a foreign gene, scientists argue that such products are equivalent to conventionally developed varieties although the process falls under genetic engineering. However, the definition for GM and regulated articles are process-based and therefore guidelines have to be revised.

Lastly, the commitment of the Philippines to the Cartagena Protocol prompted JDC-1 to include socio-economic considerations (SEC); this too needs to be revisited. While SECs include the social, ethical, and economic concerns that can potentially cover the broader risks posed by the GM product, the question remains on whether SECs should be a mandatory requirement.

This paper discusses the above regulatory issues and concerns that need to be addressed by the Philippine regulatory system. There are already some initiatives being undertaken, and options which the country can pursue in moving forward.  The first section tackles the gap on mechanisms for liability and redress in addressing damage from LMOs. The second section discusses the emergence of NBTs and how this fits with the regulatory system. Finally, the last section looks at the implications of including/excluding socio-economic considerations.

GAP ON LIABILITY AND REDRESS

The Nagoya-Kuala Lumpur Supplementary Protocol

Article 27 in the Cartagena Protocol provided the opportunity for countries to establish laws and procedures addressing damage arising from the transboundary movement of GMOs, materializing into the Nagoya-Kuala Lumpur Supplementary Protocol on Liability and Redress. The Supplementary Protocol puts persons (termed as operators) liable or responsible for damage caused by GMOs, ensuring they will undertake measures that will redress/remedy the damage (CropLife International, 2013). To be considered as damage, the conservation and sustainable use of biological diversity, or human health should be affected first, characterized by an adverse, measurable and significant effect (Nijar, 2012). There are two pathways to deal with the damage. First, in the administrative approach, a national authority has the power to identify and require the operator to take measures for the damage, or even implement response measures itself. Second, the civil liability approach defers to the domestic laws to settle the damage. The Nagoya-KL Supplementary Protocol has been open for signature and ratification since 2010 and as of October 2020, there are already 48 countries ratified to the Supplementary Protocol. However, the Philippines has not made a move to sign the Supplementary Protocol. As the Philippines continue to deal with GMOs, it may be worthwhile to consider having a liability and redress mechanism, but the limitations in adopting such mechanism should be also understood first. The next few sections weighs in on the factors at stake for the Philippines in ratifying the Supplementary Protocol.

Benefits of the Supplementary Protocol

With an established mechanism for liability and redress, it may promote an enabling environment for maximizing the benefit from GMOs. The mechanism will serve as fall back in the event of damage. In particular, countries with insufficient resources and are biological diversity hotspots will have more incentives to establish a liability regime (Santoso 2016). The Supplementary Protocol may also help implement the polluter who pays principle, where the cost of damage repair is shifted on the person liable and not on the society (Santoso et al., 2018). While that principle is already applied with regards to environmental damage, the Supplementary Protocol makes it relevant in the context of GMOs (de Guzman, 2001). Furthermore, many provisions, especially the article on civil liability procedures, defer to the domestic law which imposes a sense of flexibility on the countries. After all, the instrument was made a Supplementary Protocol instead of an amendment to the CPB to allow countries to assess whether ratification would align with their national priorities and interests, and to decide their own procedures for pursuing response measures (Jungcurt and Schabus, 2010). This provides room for the rules and procedures to fit in the context of the countries for easier implementation. The Supplementary Protocol may also provide an incentive to comply with environmental norms (Santoso et al,. 2018). The possibility of being liable to a damage and the burden for undertaking response measures may influence the operator to take more precautionary and preventive measures during its activities. In this sense, the extra caution to be exercised may generally lessen the possibility of damage occurrence.

Underlying issues of the Supplementary Protocol

There are challenges in the implementation of the Supplementary Protocol. First, the provisions are largely administrative in nature, owing to the lone article dedicated for the civil liability. Consequently, developing countries that are unfamiliar with the administrative approach may struggle in the implementation of the Supplementary Protocol. Second, substantial resources are needed to implement the Supplementary Protocol. During the negotiations, the financial guarantee is particularly a major point of discussion (Gupta and Orsini, 2017). This issue is particularly relevant when small operators become liable to large damage that is beyond their capacity to compensate. In the event that the operator fails to provide remedy, countries must be financially prepared to ensure that compensations or response measures will still happen. Financial resources are also needed in determining the occurrence of damage. For example, a baseline data is required in order to establish the occurrence of damage (Santoso et al.. 2018). Conducting the baselining activity, and even up to the monitoring and detection of damage, would require financial resources, and manpower as well.

The problem of counterfeit seeds

Damage can still occur through the use or movement of GMOs within the national boundary. However, the Nagoya-KL Supplementary Protocol was formulated to address only the potential damage coming from the transboundary movement of GMOs. Nevertheless, the principles and procedures in addressing damage provided in the Supplementary Protocol are still applicable to domestic damage. This can be the opportunity to establish a mechanism in addressing domestic damages, especially for countries already using GMOs without a formal liability regime. In the context of the Philippines, the issue of counterfeit seeds may be relevant in the discussions on the ratification to the Supplementary Protocol.

Counterfeit seeds contain the traits of a GM Corn that did not undergo the rigorous regulatory process, and are produced and sold by unauthorized people. Counterfeit seeds come in two forms: “ukay-ukay” seeds and “sige-sige” seeds. “Ukay-ukay” seeds are pilfered seeds from production areas, while “sige-sige” seeds are the offspring of the F1 GM seeds, consequently losing the vigor of the resistance trait (Aguiba, 2018). Counterfeit GM seeds are sold as conventional seeds, and thus, do not come with a refuge system as required for insect resistance management (IRM). The seed industry reported that the proliferation of counterfeit GM Corn seeds resulted in a decline of 18.6% in the adoption rate of GM corn in 2016 (Arcalas, 2018).

The inadequate implementation of the refuge system could encourage the evolution of the target pest resistance to the Bt toxin in GM corn, possibly compromising the effectivity of the GM technology and discouraging adoption by farmers (Bourguet et al., 2005). Superior pest populations may develop that will make pest management methods ineffective, and could adversely affect and damage biodiversity in the long run (Dhillon et al., 2011).

While there is no evidence yet to prove damage from counterfeit seeds, the potential of these seeds, and of GMOs in general, to cause damage should not be undermined. The need for a liability and redress mechanism is recognized, but necessary preparation in terms of financial resources and manpower is required to implement such mechanism. The Philippines may not be adequately equipped with the requirements for the implementation, considering that the country has not made a move on the Supplementary Protocol for several years. Nevertheless, the Philippines should still prepare for the possibility of ratification considering that there will be more engagement on biotechnology activities as indicated by the ongoing review of the existing regulatory system.

IMPLEMENTATION OF SOCIO-ECONOMIC CONSIDERATIONS

Legal basis of SECs

Regulatory oversight under the Cartagena Protocol largely focuses on the science-based risk assessment of GM products in relation to the human health and environment. However, Article 26 of the Cartagena Protocol also leaves the possibility for countries to include the broader concerns of the public during the assessment, such as socio-economic considerations (Falck-Zepeda, 2009). The Protocol did not formalize the procedures in implementing SECs, which leaves flexibility for countries. In response, several countries including the Philippines, Brazil, and Kenya have expressed their willingness to include SECs in their frameworks (Falck-Zepeda 2009). Nevertheless, compliance with including socio-economic considerations in the decision making has been controversial among countries, and still remains as a major point of contention up to now. 

In the Philippines, SECs are reflected in the National Biosafety Framework (NBF) and JDC-1. The NBF required the issuing of guidelines for the conduct of socio-economic assessments, in which the effects on small farmers, indigenous people, and women among others will be accounted for. SECs are incorporated in the JDC-1 through the application process where a questionnaire regarding the potential socio-economic impacts of the product are answered and submitted. The SEC submissions are then evaluated by a biosafety committee, which may tap specially-appointed experts. However, proposals in the ongoing review of the JDC shifts the language of SEC inclusion from “shall take into account” into “may take into account” suggesting that SECs will now be optional and not mandatory. This aligns with the language provided in the CPB. Public consultations will be the avenue to account for SECs instead the application process. 

Benefits and implications of SEC inclusion

Some countries like Norway, Mexico, Thailand, and Egypt have increasingly incorporated SECs into their frameworks, moving away from science-based assessments and towards the broader and less quantifiable issues such as the societal and ethical concerns (Smyth and Phillips, 2014). Arguments for supporting the inclusion of SECs point out their relevance in protecting the rural and indigenous communities and their livelihoods against the negative impacts of GMOs to (Falck-Zepeda, 2009). The discussion regarding SECs is particularly relevant in countries that are biodiversity hotspots (Catacora-Vargas, 2012). Furthermore, there is a recognition that responsibility for each technological intervention does not end in the confinement of laboratories, and that developers have a social responsibility to fulfill once their products enter the market (Catacora-Vargas, 2012).

Inclusion of SECs will have several implications in the regulation. First, they may complicate the current biosafety regulatory process, especially in the decision-making (Mampuys, 2018). Scenarios may occur where the product is determined to be safe during the biosafety assessment but fails during the socio-economic assessment. It begs the question of how SECs will weigh against scientific evidence in reaching a decision for approval of the product. Second, clear rules and procedures must be in place to establish a predictable regulatory system. The imparted certainty and robustness can boost the interest of developers and encourage them to invest more in product development.

Lastly, there is also a corresponding increase in the regulatory cost and delays for each assessment which vary depending on the scope of the study (Falck-Zepeda and Zambrano, 2011). More resources and specialized personnel will be required for conducting such assessments, in which countries with insufficient capacity will experience difficulties. Higher cost may force public institutions with less available resources to explore other non-regulated technologies, potentially reducing the number of technologies to be released for the public (Falck-Zepeda and Zambrano, 2011). While the added cost will have direct impacts, a study has shown that delays will even have more impact in decreasing net benefits compared with the cost (Bayer et al,. 2010).

Politicization of SECs

While there are perceived benefits for society, experience shows that the societal dimension may not be the only focus of the SECs. As socio-economic considerations take on a bigger role in the regulation, product assessments tend to be more subject to politicization. Decisions will then be impacted more by the pressure exerted by environmental non-government organizations (eNGOs) lobbying against GMOs (Smyth and Phillips, 2014). Experience from countries that shaped their regulatory system using SECs such as in the European Union and Norway demonstrate how the political dimension is exploited in decision-making. In the EU, politicization is apparent where the precautionary principle is used as an excuse by politicians for banning GMOs despite having science-based information on the safety of GMOs (Aerni 2019). In Norway, GM Corn was prohibited in the country because of the skepticisms expressed by the public, particularly from non-government organizations and farmer unions, even if the product did not represent negative effects on health (Myskja and Myhr, 2020). These examples demonstrate how political pressure can be decisive in the decision-making for GM approval with little regard to scientific evidence.

Looking forward

The potential benefits of the inclusion of SECs in the decision making are already recognized internationally and our country has already expressed its interest. However, partaking in such direction entails rigorous preparation in terms of the capacity to implement and incorporate such assessments in the regulation. The inclusion of SECs in regulation also makes decision-making prone to political pressure, even if the biosafety assessments prove the safety of the products. Considering the ongoing JDC-1 reform that shifts the implementation of SECs to optional, SECs will have a limited role in decision-making which reduces the possibility for politicization of the regulation, while also promoting a science-based regulation. The reform also helps shape a more manageable system considering that the Philippines already lacks the needed resources to conduct socio-economic assessments. In hindsight, the reform on SECs may prove advantageous to the Philippines as it engages deeper in biotechnology.  

UNCERTAINTY AROUND NEW BREEDING TECHNIQUES

New plant breeding innovations

For many years, genetic engineering has been the premier molecular technique for plant breeding, which was also the basis for the establishment of regulation worldwide. However, science has come a long way as new and more sophisticated techniques based from the increased understanding of plant breeding has emerged in the past decade. The collection of these new techniques is termed as New Breeding Techniques.

NBTs shows promise as a tool for crop improvement by inducing genetic change not possible before. First, while genetic engineering allows the insertion of foreign DNA into cells, gene editing is capable of imparting genetic modification using the target organism’s own genome without having to transfer a whole gene from a different organism. Second, the highly precise nature of NBTs allow changes at specific sites in the genome with minimal unintended modifications, compared with the random, and consequently prone to off-site changes of genetic engineering techniques (Wolter et al,. 2019). Lastly, genetic engineering can only modify single traits, but NBTs allow simultaneous manipulation of multiple traits (Wolter et al,. 2019). The use of NBTs makes it advantageous to work with traits relevant to improving agricultural productivity such as disease resistance, insect resistance, and abiotic stress tolerance.

NBTs result to a large spectrum of products that fall between the products of genetic engineering and conventional breeding. Some techniques are only an improvement of conventional techniques (SDN1, SDN2), consequently inducing changes that are commonly found in nature or from techniques with a proven history of safe use (Sprink et al., 2016). Furthermore, those techniques result to final products without gene insertions, escaping the GM regulation (Araki and Ishii, 2015). Other techniques insert genes (SDN3) resulting to transgenic products or GMOs, qualifying for GM regulation. The heterogeneity of NBT products is the main challenge for regulation.

The problem of regulation

The existing GM regulation is process-based, where all products derived through genetic engineering are regulated, irrelevant of the characteristics of the final product. This is because the regulation was established in response to genetic engineering. Since similar products should be given the same level of regulatory oversight, it is logical that NBT products similar to their conventionally-bred counterparts should not trigger GM regulation (Conko et al,. 2016). However, the existing regulation does not distinguish these NBT products, and would instead classify them under the regulation. Therefore, the existing GM regulation is unfit for giving the NBT innovations commensurate regulatory oversight (Davison and Ammann, 2017). This posits the need to update the regulation into a product-based regulation.

The concept of a product-based regulation is aligned with the accumulated scientific development and experience in the past decades. Using the studies already conducted, the scientific community has reached a conclusion that the process used to produce an organism, whether it would be genetic engineering or any molecular tools, is unrelated to the level of risk of the resulting product (Conko et al., 2016). Therefore, in order to formulate a scientifically sound regulation, the product should be the primary consideration in deciding its regulation and not the process used to obtain the product (McHughen, 2016). Initiatives to address these NBTs through a product-based regulation have already started in the Philippines, which will be discussed in the next section.

Regulatory status of NBTs in the Philippines

In 2018, a team composed of Dr. Reynante L. Ordonio, Atty. Paz J. Benavidez II, Atty. Edmund Jason G. Baranda and Dr. Ruben L. Villareal was commissioned to review the research and regulatory landscape of NBTs and come up with a material that will help regulators formulate the appropriate framework. For the purpose of the study, the team set a criterion for determining regulation and consequently reviewed the known techniques as of 2018 whether they would give rise to products that will be regulated.

In the existing biosafety regulation, the articles produced using modern biotechnology and in possession of novel combinations of genetic materials will be subject to regulation, in which the term “novel combinations” is not defined. For the purpose of the study, the team came up with the definition as “those not likely formed in nature or not possible through conventional breeding” (Baranda et al., 2018). The proposal is well aligned with the scientifically-sound product-based regulation, as the regulation will only be triggered if the final products contain novel combinations.

In the same material, a fragment length threshold was also proposed where introduction of fragments shorter or equal to 19-base pairs (bp) can be considered as native sequences and thus would not be regulated, while sequences with at least 20-bp will trigger a review if the product falls under the regulation. However, in the update presented by Dr. Cariño last October 13, 2020 in the webinar “Regulation and Genome Edited Plants” organized by CGIAR, this rule was not mentioned in the current regulation update in the Philippines and might have been dropped. Nevertheless, the proposed definition for the novel combinations was retained. The updates to the Philippine regulation are expected to be released in the near future.

Looking forward

Rapid development in science for only a few years resulted to the current plethora of NBTs, and scientific progress is expected to be faster in the coming years. The emergence of NBTs exposed the problem that the existing legal framework has been outpaced and outdated by the scientific progress, causing a growing gap between innovation and regulation. Policy development will then be critical as it would influence the next generation of researches and innovations. This includes the technology transfer from the international scene into the country as well. Considering that local development alone would not support biotechnology development in the country, the Philippines should then work towards a more science-sensitive regulation, where the global scientific understanding on biotechnology is recognized and accommodated. This would encourage and permit knowledge-sharing, technology transfer, and trade of biotechnology innovations with other countries. Moving forward, as we continue to engage deeper in biotechnology, regulatory reforms should also be directed towards international harmonization.

CONCLUSION

There is an opportunity to address the pressing issues surrounding the GM regulation. Complying with the obligations on the Cartagena Protocol regarding liability and redress and SECs would require resources that the Philippines does not adequately have, which poses a challenge to their implementation. The country will have to delay its ratification to the Supplementary Protocol, but the need for a liability and redress mechanism should be considered in the future. The implementation of SECs will have to settle on a limited role as provided in the ongoing JDC-1 reform, emphasizing a science-based regulation. The regulatory update to accommodate NBTs through a product-based approach is scientifically sound, but further steps should be directed towards regulatory harmonization. The current initiatives will not only help the Philippines regain its momentum, but also help sustain engagements in biotechnology in the coming years.

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