research paper about issues on philippine biosafety policies

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Philippine biosafety regulatory gaps and initiatives.

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.

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.

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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Assessment of the Biosafety and Biosecurity Landscape in the Philippines and the Development of the National Biorisk Management Framework

Affiliations.

• 1 National Training Center for Biosafety and Biosecurity, National Institutes of Health, University of the Philippines-Manila, Manila, Philippines.
• 2 Institute of Health Policy and Development Studies, National Institutes of Health, University of the Philippines-Manila, Manila, Philippines.
• PMID: 36034094
• PMCID: PMC9134340
• DOI: 10.1089/apb.20.0070

Introduction: The emergence of biological threats that can potentially affect millions emphasizes the need to develop a policy framework in the Philippines that can mount an adequate and well-coordinated response. The objective of the study was to assess, strengthen, and harmonize efforts in biorisk management through the development of a National Biorisk Management Framework. Methods: The development of the National Biorisk Management Framework was carried out in two phases: (1) assessment of the current biosafety and biosecurity landscape and (2) framework development. Results: This study identified policy gaps in the incorporation of biosafety in course curricula, professional development, and organizational twinning. The desired policy outcomes focus on increasing the capacity and quality of facilities, and the development of the biosafety officer profession. The tabletop exercises revealed weak implementation of existing protocols and unclear coordination mechanisms for emergency response. Based on these, a framework was drafted composed of eight key areas in biosafety and biosecurity, and four key contexts in risk reduction and management. Discussion and Conclusion: Reforms in biosafety and biosecurity policies are expected to improve coordination, ensure sustainability, capacitate facilities, and professionalize biosafety officers. Because of the complexity of reforms necessary, success will require a consistent and coherent policy framework that (1) provides well-coordinated mechanisms toward harmonized risk reduction and management, (2) establishes and enforces guidelines on biosafety, biosecurity, and biorisk management, (3) regulates facilities essential for occupational safety and public health, and (4) is financed by the General Appropriations Act as part of the national budget.

Keywords: biorisk management; biosafety; biosecurity; policy analysis; policy gaps.

© Raul V. Destura et al. 2021; Published by Mary Ann Liebert, Inc.

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Modern biotechnology application and regulation in the philippines: issues and prospects.

Modern crop biotechnology is being considered as a novel solution to the long-standing problems of food insecurity, low crop productivity, pest and disease prevalence, and micronutrient deficiency, particularly in developing and climate-vulnerable economies. Empirical evidence of its benefits encouraged the development and adoption of genetically modified organisms (GMOs) and related products, fostering global market dynamism. The Philippines' early adoption of technology and its inclusion among countries with the highest GMO corn hectarage in the early 2000s motivated the creation of regulatory guidelines and biosafety policies which informed development and commercialization timelines. The study reviewed the enabling regulatory structures to determine entry points for augmentation while an economic surplus analysis of GMO eggplant was carried out as a case study to estimate welfare benefits and potential opportunity costs for both consumers and local growers. Results showed that across simulations, even with the most conservative adoption delays due to regulatory lags, viable figures were still obtained with the lowest IRR at 20 percent. Notwithstanding contrary sentiments from interest groups, the government's priority must be to make available the modern biotechnology option, in both farm and household tables, in the most prudent but expedient way possible. The huge opportunity losses attached to suboptimal bureaucratic regulatory functioning have to be stemmed.

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• Appl Biosaf
• v.26(4); December 2021

Assessment of the Biosafety and Biosecurity Landscape in the Philippines and the Development of the National Biorisk Management Framework

Raul v. destura.

1 National Training Center for Biosafety and Biosecurity, National Institutes of Health, University of the Philippines-Manila, Manila, Philippines.

Hilton Y. Lam

2 Institute of Health Policy and Development Studies, National Institutes of Health, University of the Philippines-Manila, Manila, Philippines.

Rohani C. Navarro

Jaifred christian f. lopez, reneepearl kim p. sales, ma. ida faye a. gomez, angelo dela tonga, gianne eduard ulanday.

Introduction: The emergence of biological threats that can potentially affect millions emphasizes the need to develop a policy framework in the Philippines that can mount an adequate and well-coordinated response. The objective of the study was to assess, strengthen, and harmonize efforts in biorisk management through the development of a National Biorisk Management Framework.

Methods: The development of the National Biorisk Management Framework was carried out in two phases: (1) assessment of the current biosafety and biosecurity landscape and (2) framework development.

Results: This study identified policy gaps in the incorporation of biosafety in course curricula, professional development, and organizational twinning. The desired policy outcomes focus on increasing the capacity and quality of facilities, and the development of the biosafety officer profession. The tabletop exercises revealed weak implementation of existing protocols and unclear coordination mechanisms for emergency response. Based on these, a framework was drafted composed of eight key areas in biosafety and biosecurity, and four key contexts in risk reduction and management.

Discussion and Conclusion: Reforms in biosafety and biosecurity policies are expected to improve coordination, ensure sustainability, capacitate facilities, and professionalize biosafety officers. Because of the complexity of reforms necessary, success will require a consistent and coherent policy framework that (1) provides well-coordinated mechanisms toward harmonized risk reduction and management, (2) establishes and enforces guidelines on biosafety, biosecurity, and biorisk management, (3) regulates facilities essential for occupational safety and public health, and (4) is financed by the General Appropriations Act as part of the national budget.

Introduction

The Philippines is the first country in Southeast Asia to adapt a national biosafety guideline. The guideline, published in 1991, focuses on genetic engineering and other activities that require the importation, introduction, field release, and breeding of nonindigenous organisms. 1 The country signed into the Cartagena Protocol on Biosafety to the Convention on Biological Diversity in 2000. The protocol aims 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 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.” 2 After this, a national biosafety framework was developed in 2004 and formally established through executive order (EO) 514 in 2006. The framework applies to products of biotechnology and exotic and invasive alien species, with focus on their research, development, handling, use, transboundary movement, release into the environment, and management. 3

Despite the progress made in the mentioned areas, there are issues included within the field of biosafety and biosecurity that needs to be given attention in the Philippines similar to how they are considered in other countries. In developed countries, this involves the regulation of dual use of research concern (DURC). 4 Scientific research has benefited the world population through the development of health, agriculture, and environment technologies. 5 , 6 However, there continues to be a concern regarding the potential of biological research to be misused. Research with high misuse potential include those that (1) manipulate pathogenicity or virulence; (2) synthesize pathogens and toxins without cultivation of microorganisms; (3) identify new mechanisms to disrupt the healthy functioning of humans, animals, or plants; and (4) develop novel means of biological agents and toxins delivery. 7 Management approaches to DURC have focused on policies that govern research mechanisms, funding agencies, journal publishers, codes of conduct and ethics, and education initiatives for a wide range of audiences. 7–13

In the Asia–Pacific region, the idea of biosafety and biosecurity holds stronger ties to agricultural security, biodiversity, and public health over national security concerns such as biological warfare or terrorism. In particular, outbreaks of zoonotic viruses over the past two decades have given way for governments to prioritize the public health aspect of biosafety and biosecurity through the lens of agricultural and animal farming practices. 14 The quick spread of these outbreaks (severe acute respiratory syndrome [SARS] in 2003, Influenza A virus subtype H5N1 [H5N1] in 2005, Influenza A virus subtype H1N1 [H1N1] in 2009, and coronavirus disease 2019 [COVID-19] in 2020) has highlighted the need to consider biosafety and biosecurity as a national and even global issue. 15–18

As the bioscience and laboratory industry grows in Asia, so does the need to consider the industry's role in national biosafety, biosecurity, and the larger global health security. 19 Handling pathogenic organisms requires good laboratory practices, risk assessments, and biorisk measures to prevent accidental or deliberate infection. 20 Between 1982 and 2016, 27 laboratory-acquired infections (LAIs) were published in the Asia–Pacific. Fifty-two percent of the LAIs occurred in research laboratories. 20 These LAIs occurred amid an ongoing lack of specialist-level training for biosafety and biosecurity protocols in the region. In a 2010 survey of 197 life science degree courses from 58 Asian universities, it was found that only 2% had biosecurity modules, 18% had biosafety modules, and 10% had topics on the dual use of science. 14 It is important to note that 78% of the reported LAIs in Asia–Pacific were from developed countries, who likely report LAIs as part of both national and international standards compliance. 20

In addition, the perceived weakest link among developing countries in biosafety is that many facilities that handle infectious agents were built >10 years ago and designed with limited consideration for biosafety and security. 4 A 2007 survey on bioscience research practices in Asia found that 20% of scientists do not use personal protective equipment, 50% of facilities do not have an autoclave, 50% do not restrict laboratory access at all times, and up to 33% lack training on biosafety protocols. 21

The emergence of biological threats that can potentially affect millions emphasizes the need to develop a policy framework that can mount an adequate and well-coordinated response. The objective of the study was to assess, strengthen, and harmonize efforts in biorisk management through the development of a National Biorisk Management Framework.

Methodology

This initiative was funded by University of the Philippines Manila National Institutes of Health and U.S. Defense Threat Reduction Agency-Biological Threat Reduction Program. This study did not require ethics approval as it did not involve any studies with human or animal subjects. The development of the National Biorisk Management Framework was carried out in two phases ( Figure 1 ): (1) assessment of the current biosafety and biosecurity landscape and (2) framework development.

Methodology process.

Phase 1: Assessment of the Current Landscape

Policy review.

This step entailed a rapid scan and review of existing policies related to biosafety and biosecurity in the Philippines. Policies were searched in the laws and policies databases of six concerned government institutions. After retrieval of policies, a data extraction table was made to map the policies. Data extracted from the policies included title of policy, entity or subject covered by the policy, date published, type of policy, agency that published the policy, and its objectives.

The review and analysis of the policies were anchored to the nine categories for developing sustainable capacity for biosafety and biosecurity in low-resource countries: (1) country-/region-specific regulatory framework and guidelines or standards, (2) biosafety and biosecurity awareness, (3) infrastructure, (4) equipment, reagents, and services, (5) management and administrative controls, (6) biosafety curricula, (7) training, (8) biosafety associations, professional competency, and credentialing, and (9) individual mentoring and organizational twinning. 22

Stakeholder analysis

Stakeholder analysis is “a process of systematically gathering and analyzing information to determine whose interests should be taken into account when developing and/or implementing a policy or program.” 23 This analysis is conducted before policy is implemented for policymakers to detect and act to prevent potential misunderstandings about and/or opposition to the policy or program.

Forty-six participants were involved in the stakeholder analysis activity. The participants, majority of whom are biosafety officers, were divided into seven groups categorized as academe (3), clinical (2), research (1), and associations and private sector (1). Each group was first asked to identify stakeholders with the following guide questions 24 :

• Who will be affected?
• Will the impact be local, national, or international?
• Who has the power to influence the outcome?
• Who are the potential allies and opponents?
• Are there people whose voices or interests in the issue may not be heard?
• Who will be responsible for managing the outcome?
• Who can contribute financial or technical resources?

After stakeholder identification, each group was tasked to fill in a stakeholder analysis table designed to provide the following information:

• Stakeholder involved
• Ideal roles of the stakeholder
• Basis of each ideal role
• Resources available to stakeholder
• Adequacy of resources available to the stakeholder
• Possible reaction of the stakeholder to a biosafety framework for nongenetically modified organism (GMO) facilities

Groups presented their outputs to the plenary, followed by a synthesis to verify, consolidate, and agree upon the identified stakeholders, and their roles, resources, and reactions to the policy framework being developed.

Policy outcome activity

Policy outcomes are short- or long-term changes after policy implementation and the extent to which those changes can be attributed to the policy. 25 As part of the policy process, early identification of desired outcomes and its evaluation may inform and improve policy development, adaption, implementation, effectiveness, and build evidence for policy interventions. 26

Thirty-eight participants were involved in the activity. The participants, majority of whom are biosafety officers, were divided into six groups: academe (3), clinical (2), and research, associations, and private sector (1).

Each group was tasked to come up with a list of their desired policy outcomes with this question in mind: “What does success look like for this policy framework?” The lists were collected and synthesized by the moderator then presented to the plenary for validation. As a plenary, the pros and cons of each desired policy outcome were identified.

To identify the top three desired policy outcomes, each participant was allotted three votes. Participants could distribute their three votes equally to their top three choices, limit themselves to two choices by preferring one over another, or give all their three votes to one desired policy outcome. A secret ballot method was used to ensure anonymity of choices by the participants. The casting of votes by each participant was overseen by two moderators to ensure each participant did not exceed their three-vote limit.

Tabletop exercise and gap analysis

A tabletop exercise makes use of the participatory approach and calls on key emergency response personnel to discuss a given simulated emergency situation. Participants usually discuss which specific steps to take and what roles are assigned at each stage of the emergency. 27 Tabletop exercises provide insights into the strengths and weaknesses of public health emergency preparedness and address these gaps by assessing capabilities, training staff, and forging relationships. 28

Fifteen participants in total were involved in the tabletop exercise, representing government agencies and academe. Two groups were formed, one group with eight members and another with seven members. Both groups were tasked to discuss existing response mechanisms activated and communications required in all phases and subevents in a scenario involving a suspected disease outbreak of African swine fever in a setting similar to the Philippines ( Table 1 ). Discussions were facilitated within each group as each phase of the biological incident was presented. If a capability or communication was considered a necessity by the circumstances outlined in the scenario but was not a real-world capability, it was thus identified as a gap.

Events and subevents in the tabletop exercise

ASF, African swine fever; RADDL, Regional Animal Disease Diagnostic Laboratory.

Phase 2: Framework Development

Key assessment results from Phase 1 were used to draft the National Biorisk Management Framework. A Charter Working Group (CWG) was formed to aid in framework development. Representatives were rigorously chosen based on their authority and expertise in the field of agriculture, health, laboratories, industry, and security.

Three consultations were held on November 5, November 28, and December 3, 2018. During the series of meetings, the CWG members were presented the draft biorisk management framework and asked to investigate the framework in detail, provide feedback, identify key issues, and provide valuable technical input relevant to their area of expertise.

Policy Review

The search strategy yielded a total of 41 issuances composed of 22 administrative orders, 6 republic acts, 7 guidelines, 2 department circulars, 2 EOs, 1 manual, and 1 United Nations Resolution. Biosafety and biosecurity in the Philippines is mainly anchored on four policies ( Table 2 ).

Four main policies and their objectives

EO, executive order.

The policies and issuances scoped cover 27 regulatory subjects, which include health products, facilities, animals, plants, and drugs, among others. Issuances covering each regulatory subject were analyzed according to the nine categories for developing sustainable capacity for biosafety and biosecurity in low-resource countries ( Table 3 ). 22

Summary of policies and regulatory subjects covered according to nine categories for developing sustainable capacity for biosafety and biosecurity in low-resource countries

Heckert et al. 22

EVD, Ebola virus disease; GMOs, genetically modified organisms; HFMD, hand, foot, and mouth disease; MERS-COV, Middle East respiratory syndrome coronavirus; TB, tuberculosis.

Country-/region-specific regulatory framework and guidelines or standards

Seventeen of the 27 entities follow a specific regulatory framework, guideline, or standard. These are determined by a government agency, a committee or board, or follow existing international guidelines. The frameworks are usually concerned with regulation of an entity and include establishment of standards, practices, and monitoring and evaluation plan.

Biosafety awareness

Three out of the 27 entities have policies that discuss awareness. It includes mandates on biosafety promotion, participation, and development of advocacy materials and risk communication plans. It also states the need for policymakers to be aware and provided with sufficient and current information on biosafety.

Infrastructure

Sixteen of 27 entities have policies related to infrastructure. The level of detail provided in the guidelines for infrastructure varies between entities. Some entities, such as animal facilities and clinical laboratories, are provided with broad guidelines. Conversely, guidelines for GMOs provide detailed information for physical containment according to four biosafety levels.

Management processes and administrative controls

Nineteen of the 27 entities are provided with governance mechanisms through a policy. A government agency, a network of agencies, or a committee created through an issuance oversees the implementation of a policy framework, guidelines, or standards. These policies also outline the responsibilities of municipal, city, and regional counterparts of national offices, when applicable.

Eight of 27 entities are provided with training guidelines in their handling, transport, and use for staff. The policies outline capacity-building programs, continuing education programs, and minimum training and skill requirements for staff.

No mandates were found for the following categories: biosafety curricula; biosafety association, professional competency, and credentialing; and individual mentoring and organizational twinning.

Stakeholder Analysis

A total of 28 stakeholders were identified by the participants. Twenty-two of the 28 identified stakeholders were government institutions. Six stakeholders identified include academic institutions, training centers, associations, and civil society organizations. Identified stakeholders were further analyzed according to ideal roles, basis for ideal role, resources available and adequacy, and reaction to framework.

Ideal roles and basis for ideal role

Ideal roles identified by the participants closely follow current functions that the various stakeholders already perform. Most roles are concerned with the integration or strengthening of existing rules and regulations for biosafety and biosecurity. Twenty-four out of 28 stakeholders have a legal mandate as basis for the roles identified to them by the participants ( Table 4 ).

Ideal roles of identified stakeholders

BMC, biological materials of concern.

Resources available and adequacy

Commonly identified resources available to the stakeholders were legislation, funding, capacity building, manpower, and facility/technology/machinery ( Table 5 ).

Resources available and adequacy of identified resources

Possible reaction of stakeholder to being included in proposed policy framework

Participants strongly linked receptiveness with the ideal roles identified to the stakeholders. Stakeholders who are currently performing their ideal roles or have the resources to perform them were perceived to be more receptive. Stakeholders with unfamiliar functions or mandates to participants were less likely to be perceived as receptive ( Table 6 ).

Possible reaction to inclusion in framework

Policy Outcome Activity

A total of 114 votes were cast by 38 participants ( Table 7 ). The top three desired policy outcomes were (1) capacitating existing facilities to comply with the proposed policy, (2) professionalization of biosafety officer/creation of plantilla (a government-approved regular position), and (3) enhancing quality of laboratories.

Policy outcome activity results

ABOT, Advanced Biosafety Officer Training; CPD, Continuing Professional Development.

The desired policy outcomes were concerned with improving responsiveness and equity of facilities. This is manifested in the identified pros and cons of the outcomes. Pros include improved quality, increased client satisfaction, conduct of safe research, and increased employee satisfaction and retention. Cons identified include lack of budget, unrealistic timelines, lack of accountability, decreased access to facilities due to shutdowns, worker fatigue, and lack of manpower.

Tabletop Exercise and Gap Analysis

Based on the discussions, current response mechanisms are initiated with (1) an investigation and preparation of a case report by the lead veterinarian, (2) handling and transport of samples to the designated Regional Animal Disease Diagnostic Laboratory, (3) coordination between animal and human health response, (4) activation of reporting mechanisms to the local government unit and other concerned agencies, (5) monitoring and surveillance of other farms in surrounding areas, (6) quarantine efforts, (7) interagency coordination at the local level, (8) channeling of information from local to national actors, and (9) media and press relations.

Across the existing response mechanisms already mentioned above, the following common gaps were revealed ( Table 8 ): weak implementation or noncompliance to existing standards and protocols, unclear coordination mechanisms for emergency response, lack of training and education, and limitations in human resources and infrastructure.

Gap analysis results

HR, human resource; SOPs, standard operating protocols.

Framework Development

Discussions in the three CWG meetings resulted to feedback on (1) framework design and (2) political strategy. Key recommendations are described hereunder.

To reconsider the formation of a new agency

Early drafts of the framework incorporated the establishment of the Biorisk Management Coordinating Agency, but the CWG advised against putting up a new agency, as it creates more bureaucratic processes. Instead, clarifying roles, capacitating existing institutions, and harmonizing existing efforts were recommended.

To anchor on key functions in biosafety and biosecurity

The design must be based on functions that need to be fulfilled in terms of biosafety and biosecurity, adopting a bottom-up approach, and incorporating inputs from frontline actors. These functions form the key areas of the framework in its current form.

To incorporate the four pillars of disaster risk reduction and management in the context of biohazards

Early drafts of the framework lacked proper emphasis on disaster risk reduction and management. The CWG advised the incorporation of the four pillars of disaster risk reduction and management, namely prevention and mitigation, preparedness, response, and rehabilitation and recovery, as the key contexts of the framework in its current form.

To consider the pivotal role of the Office of Civil Defense under the Department of National Defense

As the secretariat of the National Disaster Risk Reduction and Management Council, the Office of Civil Defense has the power to direct various agencies when facing a threat. Thus, it was discussed as strategic to house biosafety and biosecurity functions under this office.

To consider the better policy route

The framework may be passed into law through a senate bill, house bill, or an EO signed by the president. It was agreed upon by the CWG that an EO would be the most strategic pursuit for this policy.

To address funding gaps in policy and implementation

There is a possibility that the bill may be passed into law, but not funded and thus, not properly implemented. The CWG emphasized the importance of stating clear funding mechanisms in the document.

Based on these results of the Phase 1 assessment and recommendations of the CWG, a National Biorisk Management Framework was formulated ( Figure 2 ). The proposed framework is composed of eight key areas in biosafety and biosecurity and four key contexts in risk reduction and management.

Proposed National Biorisk Management Framework.

In an increasingly connected world, emerging or re-emerging diseases and the deliberate or undeliberate release of infectious agents hold greater potential to affect populations across borders. 29 Global experience with SARS (2003), H1N1 (2009), and COVID-19 (2019) shows that pandemics have extensive health, social, and economic impact that has made the importance of biosafety and biosecurity preparedness more evident. 30–34 Advances in biotechnology has also leaped the application of biological sciences in the fields of health, agriculture, and environment, among others. However, this advancement comes with an increased risk for DURCs. 35 , 36 Although there are obvious benefits to biological research, the increased DURC risk has created a moral and ethical dilemma for the life sciences: do the benefits of the research outweigh the risks? 37 Creating a biosafety and biosecurity framework, therefore, presents the challenge of striking a balance between protecting public health while creating a sound regulatory environment necessary for research and innovation. 32 , 38

Expanding the Concepts of Biosafety and Biosecurity

The current Philippine National Biosafety Framework, EO 514, was part of a UN Environment Programme-Global Environment Facility initiative to assist countries in developing a national framework after the ratification of the Cartagena Protocol on Biosafety. The Philippines EO 514 definition of biosafety suggests that biosafety policies may apply to multiple sectors related to biosafety. However, the scope of the framework is limited to products of modern biotechnology, exotic species, and invasive alien species, leaning heavily toward the agriculture and environment sector.

This concern was also raised by participants during the stakeholder analysis. First, established policies that have already defined “biosafety” may mean that a different terminology should be used in the framework being proposed that encompasses all activities related to biosafety, extending to public health, laboratory management, and outbreak response. Second, the current definition in EO 514 focuses on the potential harm of regulated articles. However, there is a growing recognition that access to information, processes, practices, and equipment is equally important as having access to a biological or hazardous material. 39 An expanded concept may be necessary that balances the perspectives of science, security, prevention, and preparedness beyond laboratory work. 15

Adopting Principles of Disaster Risk Reduction and Management

Consistent with the definitional limitation, the current policy framework lacks emphasis on risk reduction and management functions in response to the rise of complex biological threats, regardless of the cause. The integration of biosafety and biosecurity efforts to prepare for and respond to these threats should be found at the heart of biorisk management, broadly defined as the assessment of risks, identification of measures to reduce risks, and development of processes to implement and review risk-reduction measures. 40 Although existing regulatory processes already form a significant part of risk prevention and mitigation, there should be improvement in how these functions tie up alongside other efforts in the country's overall disaster risk reduction and management framework, particularly in risk preparedness, response, rehabilitation, and recovery.

Limited Institutional Capacity and Sustainability for Regulatory Systems

The debate on whether regulation impedes innovation persists today as new technologies, particularly in the field of biological sciences, generate calls for application of the precautionary principle. 41 The precautionary principle is an approach to innovations with potential for causing harm when extensive scientific knowledge is lacking. 42 The relationship between regulation and innovation is complex and different regulatory instruments have varying effects on technological progress. 41 Although international legal frameworks for biosafety and biosecurity exist, these provide limited guidance on what constitutes a functional national regulatory framework. It is the responsibility of national governments to produce and implement evidence-based policies that apply the precautionary principle emphasized by the Cartagena Protocol on Biosafety. 36

Spearheaded by the National Committee on Biosafety of the Philippines, the implementation of policies related to biosafety is a task shared by four government agencies. The Department of Agriculture, Department of Environment and Natural Resources, Department of Health, and Department of Science and Technology have multifaceted roles that involve biosafety and biosecurity policy development, accountability, and capacity building. This current system utilizes a combination of network and traditional command and control regulation. These agencies regulate overall biosafety activities in the country while also being the sole regulatory arm of entities under their mandate.

Results of our policy review shows that the four agencies have developed policies to regulate biosafety through enforcing guidelines and standards ( Table 2 ). Although these policies have been implemented, stakeholder analysis results show limited capacity of regulators to maintain this ( Table 5 ). Insufficient institutional capacity manifests in the limited training of regulatory personnel and variations in the level of detail between and within biosafety policies of different agencies. Current policies in training refer to continuing education for facility workers in relation to biosafety but do not include regulatory personnel. This is consistent with stakeholder analysis findings, wherein participants noted that some agencies should but do not currently have the technical expertise to develop or implement policies on biosafety and biosecurity.

The lack of consensus for some agencies also shows the need to determine their structure, current competencies, and how regulators are regulated. In appointing a regulator, there should be consideration that the regulator should be as informed as the regulatees. The question of “Who regulates the regulators?” must examine which external bodies or individuals have the authority to reconsider the decisions made by the regulators. 43

Responsive regulation maintains that regulators are more likely to succeed by using mechanisms that are responsive to the context, conduct, and culture of those being regulated. 44 A command and control approach, as is currently applied in the Philippines, is an appropriate form of regulation when all parties agree to minimum standards of quality. 45 However, there is currently little involvement of the general public in regulatory functions. The Philippine National Biosafety Framework limits public participation to information related to biosafety decisions and begins only from the time an application is received. There is still a need for collaboration in disseminating regulatory standards and establishing the state's authority as a regulatory body.

Coordination Mechanisms for Emergency Response at the Local Level

The gap analysis shows that at the local level, there are existing scenario-based protocols at each phase of the emergency response to potential disease outbreaks, but harmonization is lacking. Based on the findings of the tabletop exercise, efforts in the implementation of protocols in laboratory testing and operations; monitoring and surveillance; quarantine response; veterinary and clinical disease investigation; waste disposal and decontamination, media, and; law enforcement are concrete but uncoordinated.

In an ideal setting, these mechanisms are implemented by local responders from the Bureau of Fire Protection and Philippine National Police. However, clear coordination mechanisms required to bridge the gap between public health and national security are either lacking or slow in activation. To set up a robust response strategy, multidisciplinary networks with diagnostic capabilities in law enforcement and public health, including environmental, agricultural, food, veterinary, and clinical institutions, are necessary to handle both intentional and unintentional biorisk incidents. 46

A common framework for biosafety and biosecurity must be created to accurately assess the risks posed by biological threats and ensure understanding of multidisciplinary strategies needed to mitigate them. This can be achieved by considering four key points 40 : (1) difficulty in estimating likelihood and consequences of a biological threat, (2) the need for broad and comprehensive definitions of biosafety and biosecurity to bridge the gap between national security, life sciences, and public health communities, (3) inaccurate perception of risk and its implications in the response, and (4) synergy in research and formulation of policy.

Conclusions and Recommendations

Reforms in biosafety and biosecurity policies are expected to improve coordination, ensure sustainability, capacitate facilities, and professionalize biosafety officers. Because of the complexity of reforms necessary, success will require a consistent and coherent policy framework that (1) provides well-coordinated mechanisms for multidisciplinary and multilevel communication and interaction toward harmonized risk reduction and management; (2) establishes, benchmarks, develops, implements, and enforces guidelines on biosafety, biosecurity, and biorisk management; (3) regulate facilities where implementation of such guidelines is considered essential for occupational safety and the health of the public; and (4) is financed by the General Appropriations Act as part of the national budget.

The COVID-19 pandemic has manifested the gaps identified in this study. Policies and support mechanisms that focus on workforce development, particularly on trainings and workshops, provide a low-investment but high-impact solution in reaching the reform goals. An effective training program provides a cost-efficient longer term solution for lower to middle-income economies as heavy reliance on infrastructure and engineering safeguards involves overhead costs being accrued over time, impeding local acceptance and sustainability. Awareness-level trainings to policymakers also provide a common language among stakeholders and start an avenue for collaborative discussions. These introductory trainings allow engaging champions from various sectors, increasing the likelihood of program sustainability and accelerating simultaneous capacity building among stakeholders. The multidisciplinary approach enables collaboration and linkage among agencies and other concerned entities to prepare for and respond to a biological event of any scale in a timely and consistent manner.

Author Disclosure Statement

No competing financial interests exist.

Funding Information

This study was funded by the University of the Philippines-National Institutes of Health and the U.S. Defense Threat Reduction Agency-Biological Threat Reduction Program.

Executive Order 514

BY THE PRESIDENT OF THE PHILIPPINES

EXECUTIVE ORDER NO. 514

ESTABLISHING THE NATIONAL BIOSAFETY FRAMEWORK, PRESCRIBING GUIDELINES FOR ITS IMPLEMENTATION, STRENGTHENING THE NATIONAL COMMITTEE ON BIOSAFETY OF THE PHILIPPINES, AND FOR OTHER PURPOSES

WHEREAS , there is rapid expansion of the use of modern biotechnology not only for scientific research but also for products for commercial releases and purposes;

WHEREAS , there is concern over modern biotechnology’s potential impacts on the environment, particularly on biological diversity, on human health, and on social and cultural well-being;

WHEREAS , it is the policy of the State to promote the safe and responsible use of modern biotechnology and its products as one of the several means to achieve and sustain food security, equitable access to health services, sustainable and safe environment and industry development;

WHEREAS , the Cartagena Protocol on Biosafety to the United Nations Convention on Biological Diversity which the Philippines signed on 24 May 2000 entered into force on 11 September 2003;

WHEREAS , the National Committee on Biosafety of the Philippines (NCBP), Department of Science and Technology, Department of Agriculture, Department of Health, and Department of Environment and Natural Resources have played, since 1987, a pioneering and important role in developing and establishing the current biosafety system;

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;

NOW, THEREFORE, I, GLORIA MACAPAGAL-ARROYO , President of the

Philippines, by virtue of the powers vested in me by law, do hereby order:

SECTION 1. Adoption and Operationalization of the National Biosafety Framework. The National Biosafety Framework (NBF) for the Philippines, attached hereto as Annex A, is hereby adopted.

SECTION 2. Scope and Objectives. The NBF shall have the following scope and objectives:

2.1 Scope. 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.

2.2 Objectives. The NBF shall have the following objectives:

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.

SECTION 3. Administrative Framework and Decision-Making Processes. In making biosafety decisions, the administrative system and decision-making processes established in the NBF shall be complied with.

SECTION 4. Strengthening the National Committee on Biosafety of the Philippines (NCBP). The NCBP is hereby strengthened. Its mandate, functions, composition and organization are set forth in the NBF.

SECTION 5. General Mandate on Departments, Offices and Agencies. The mandates, jurisdictions and other powers of all departments and agencies in relation to biosafety and biotechnology shall be guided by the NBF and coordinated with the NCBP and each other in exercising such powers.

SECTION 6. Funding. The DOST, DENR, DA, and DOH shall allocate funds from their present budgets to implement the NBF, including to support the operations of the NCBP and its Secretariat. Starting 2006 and thereafter, the funding requirements shall be included in the General Appropriations Bill submitted by each of said departments to Congress.

These concerned departments shall enter into agreement on the sharing of financial and technical resource to support the NCBP and its Secretariat.

SECTION 7. Transition. The NCBP and its present members shall continue to exercise their present functions under Executive Order No. 430, s. 1990 until such time that it has completely reorganized under the NBF. The reorganization shall commence immediately after the DOST, DENR, DA, and DOH have entered into an agreement on the sharing of financial and technical resources to support the NCBP and its Secretariat on a sustainable basis, and shall be completed within one year from effective date of such agreement.

All members of the NCBP to be appointed by the President, as required by the NBF, shall assume their positions upon completion of the reorganization.

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.

SECTION 9. Effectivity. This Order shall take effect fifteen days after publication in two newspapers of general circulation.

DONE, in the City of Manila, this 17th day of March in the year of our Lord two Thousand and Six.

By the President:

EDUARDO R. ERMITA Executive Secretary

NATIONAL BIOSAFETY FRAMEWORK

FOR THE PHILIPPINES

SECTION 1. CONSTITUTIONAL POLICIES

In implementing the National Biosafety Framework (NBF), the following state policies mandated by the 1987 Constitution shall guide the concerned government department and agencies:

1.1 Right to Health. The State shall protect and promote the right to health of the people and instill health consciousness among them (Article II, Section 15);

1.2 Right to a Healthy Environment. 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 (Article II, Section 16);

1.3 Priority to Science. The State shall give priority to education, science and technology, arts, culture, and sports to foster patriotism and nationalism, accelerate social progress, and promote total human liberation and development (Article II, Section 17);

1.4 Role of the Private Sector. The State recognizes the indispensable role of the private sector, encourages private enterprise, and provides incentives to needed investments (Article II, Section 20);

1.5 Rural Development. The State shall promote comprehensive rural development and agrarian reform (Article II, Section 21) and shall provide support to agriculture through appropriate technology and research, and adequate financial, production, marketing, and other support services (Article XIII, Section 5);

1.6 Right of Indigenous Peoples and Communities. The State recognizes and promotes the rights of indigenous cultural communities within the framework of national unity and development (Article II, Section 22). The State, subject to the provisions of this Constitution and national development policies and programs, shall protect the rights of indigenous cultural communities to their ancestral lands to ensure their economic, social, and cultural well-being (Article XIII, Section 5);

1.7 Right to Information. Subject to reasonable conditions prescribed by law, the State adopts and implements a policy of full public disclosure of all its transactions involving public interest (Article II, Section 28);

1.8 Local Autonomy. The territorial and political subdivisions shall enjoy local autonomy (Article 10, Section 2);

1.9 Right to Participation. The right of the people and their organizations to effective and reasonable participation at all levels of social, political, and economic decision-making shall not be abridged. The State shall, by law, facilitate the establishment of adequate consultation mechanisms (Article XIII, Section 16);

1.10 Science and Technology. Science and technology are essential for national development and progress. The State shall give priority to research and development, invention, innovation, and their utilization; and to science and technology education, training, and services. It shall support indigenous, appropriate, and self- reliant scientific and technological capabilities, and their application to the country's productive systems and national life. The State shall regulate the transfer and promote the adaptation of technology from all sources for the national benefit. It shall encourage the widest participation of private groups, local governments, and community-based organizations in the generation and utilization of science and technology (Article XIV, Sections 10 and 12); and,

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1.11 Consumer Protection. The State shall protect consumers from trade malpractice and substandard and hazardous products (Article. XVI, Section. 9).

SECTION 2. PRINCIPLES

The following principles, based on national and international law, shall apply in a mutually supportive manner to the implementation of the NBF:

2.1 Policy on Modern Biotechnology. The NBF shall be implemented in the context of the overall policy of the Philippines on modern biotechnology, to wit: The State shall promote the safe and responsible use of modern biotechnology and its products as one of the several means to achieve and sustain food security, equitable access to health services, sustainable and safe environment and industry development;

2.2 Policy on Sustainable Development. The overall policy of the Philippines on sustainable development, as laid down in Philippine Agenda 21, shall equally guide the implementation of the NBF;

2.3 A Balanced Approach. A balanced approach, which recognizes both the potential benefits and risks, shall guide the implementation of the NBF. This shall be based on recognition that modern biotechnology has significant potential for human well-being if developed and used with adequate safety measures for the environment and human health. Such approach recognizes both the potential benefits and risks of modern biotechnology to human health, agricultural productivity, food security, the livelihoods of the poor, biological diversity and the environment;

2.4 A Scientific Approach. The implementation of the NBF shall be based on the best available science and knowledge. Such science and knowledge shall be of the highest quality, multi-disciplinary, peer-reviewed, and consistent with international standards as they evolve;

2.5 Socio-economic, Cultural, and Ethical Considerations. The socio-economic, ethical and cultural benefits 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;

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;

2.7 Transparency and Public Participation. Decision taken under the NBF shall be arrived at in a transparent and participatory manner. Biosafety issues are best handled with the participation of all relevant stakeholders and organizations. They shall have appropriate access to information and the opportunity to participate responsibly and in accountable manner in biosafety decision-making processes;

2.8 Consensus Building. In making biosafety decisions, all concerned government departments and agencies shall exert all efforts to find consensus among all relevant stakeholders using well-accepted methods such as negotiation, mediation, and other appropriate dispute resolution processes. Such consensus, to be achieved in a transparent and participatory manner, shall be based on the best available science and knowledge and shall not compromise public safety and welfare;

2.9 Principle of Subsidiarity. As provided by law and where competence exists, all levels of government, including local government units, shall participate in implementing the NBF;

<!--[if !vml]--><!--[endif]--> 2.10 Availability of Remedies. Effective access to judicial and administrative proceedings, including redress and remedy, shall be available in accordance with Philippine law;

2.11 International Obligations and Cooperation. In accordance with international law, the NBF shall be implemented in a manner consistent with and mutually supportive of the international obligations of the Philippines, in particular its obligations under international trade and environmental law. Multilateral, regional and bilateral cooperation in implementing the NBF, in particular its sections on capacity building and financial resources, shall be encouraged;

2.12 Efficient Administration and Timely Decision Making. The NBF decision making process shall be conducted in an efficient, coordinated, effective, predictable, cost-effective and timely manner. Undue delay shall be avoided without compromising transparency, public participation, public safety, and public welfare; and,

2.13 Public interest and welfare. In cases of conflict in applying these principles, the principle of protecting public interest and welfare shall always prevail. No section or provision in this Framework 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.

SECTION 3. SCOPE, OBJECTIVES AND DEFINITIONS

3.1 Scope. 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.

3.2 Objectives. The NBF shall have the following objectives:

3.2.1 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;

3.2.2 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,

3.2.3 Serve as guidelines for implementing international obligations on biosafety.

3.3 Definitions. For purposes of this framework, the following terms shall mean:

3.3.1 “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;

3.3.2 “Biosafety Clearing house” is an information exchange mechanism established by the Cartagena Protocol on Biosafety to assist parties in the implementation of its provisions and to facilitate sharing and exchange of scientific, technical, environmental and legal information on, and experience with, regulated articles;

3.3.3 “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;

<!--[if !vml]--><!--[endif]-->3.3.4 “Contained use” means any operation, undertaken within a facility, installation or other physical structure, which involves genetically modified organisms that are controlled by specific measures that effectively limit their contact with, and their impact on, the external environment;

3.3.5 "Genetically modified organism” also refers to “living modified organism” 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;

3.3.6 “Handling and Use” means the process by which regulated articles are moved, carried, transported, delivered, stored or worked with;

3.3.7 “Hazard” refers to traits inherent to or activities of a regulated article that may cause harm to human or animal health or to the environment;

3.3.8 “Management” means measures adopted after the release of regulated articles to ensure their safe use and, in cases of commercial release, shall also include product monitoring and product identification;

3.3.9 "Modern biotechnology" means the application of: a) in vitro nucleic acid techniques, including recombinant deoxyribonucleic acid (DNA) or direct injection of nucleic acid into cells or organelles; or b) fusion of cells beyond the taxonomic family, that overcome natural physiological reproductive or recombination barriers and that are not techniques used in traditional breeding or selection;

3.3.10 “Product identification” refers to information on the presence of a regulated article in a particular product, as implemented by concerned departments and agencies through import and export documents, unique identification system, or similar applicable approaches such as product labeling;

3.3.11 “Product Monitoring” refers to any post-commercialization measure that provides data on the fate and effects of the regulated article, in order to confirm compliance with regulatory requirements, collect information necessary for controlling and managing potentially adverse public health or environmental situations, assess environmental quality and detect unexpected or potentially damaging effects on human and animal health and the environment. Product monitoring helps reduce uncertainty remaining from risk assessment, confirm conclusions with additional data and provide informational feedback on system status or conditions;

3.3.12 “Regulated article” refers to a genetically modified organism and its products;

3.3.13 “Risk” refers to the combination of the likelihood that an adverse consequence of a biohazardous activity or trait will occur and the magnitude of such a consequence;

3.3.14 “Risk assessment” refers to the procedure that identifies, evaluates and predicts the occurrence of possible hazards to human and animal health and the environment and designs mitigating measures to avert or minimize these hazards;

3.3.15 “Risk management” refers to appropriate mechanisms, measures and strategies to regulate, manage and control risks identified in the risk assessment including those conditions imposed by concerned departments or agencies;

3.3.16 "Transboundary movement" means the movement of a regulated article from another country to the Philippines and from the Philippines to another country; and,

3.3.17 “Transformation event” means one instance of entry, stable integration and expression of an introduced gene into a cell which then develops into a functional organism expressing the introduced gene.

SECTION 4. ADMINISTRATIVE FRAMEWORK

The administrative mechanism for biosafety decisions shall be as follows:

(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;

(b) 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

same are consistent with law and if such policies are found insufficiently addressed in existing mandates

and regulations of pertinent agencies;

(c) 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;

(d) Other concerned agencies shall coordinate with NCBP on matters that may affect biosafety decisions as provided in Sections 4.7 to 4.14;

(e) Administrative functions required under the Cartagena Protocol on Biosafety shall be performed by agencies as provided in Section 4.14 and 4.15; and,

(f) The role of stakeholders and the general public shall be recognized and taken into account as provided in Sections 6 and 7.

4.1 Mandate of the National Committee on Biosafety of the Philippines (NCBP) . The NCBP shall be the lead body to coordinate and harmonize inter-agency and multi-sector efforts to develop biosafety policies in the country (where such are not already stipulated by law) and set scientific, technical and procedural standards on actions by agencies and other sectors to promote biosafety in the Philippines; oversee the implementation of the NBF; act as a clearing house for biosafety matters; and coordinate and harmonize the efforts of all concerned agencies and departments in this regard.

4.2 Composition of the NCBP. The NCBP shall be composed of the following:

4.2.1. The Secretaries of the Departments of Science and Technology, Agriculture, Health, Environment and Natural Resources, Foreign Affairs, Trade and Industry, and Interior and Local Governments or their designated representatives. The DOST Secretary shall be the permanent Chair;

4.2.2 A consumer representative appointed by the President from a list submitted by nationally recognized consumer organizations, serving for a term of three (3) years, renewable for another term;

4.2.3 A community representative from the farmers, fisherfolk and indigenous sector appointed by the President from a list submitted by nationally recognized sectoral organizations, serving for a term of three (3) years, renewable for another term;

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,

4.2.5 A biological scientist, physical scientist, environmental scientist, health scientist, and social scientist to be endorsed by the DOST Secretary upon the recommendation of recognized professional and collegial bodies such as the National Academy of Science and Technology (NAST) and the Philippine Social Science Council (PSSC), and appointed by the President, each serving for a term of three (3) years, renewable for another term.

4.3 NCBP Executive Committee and Technical Working Groups. The NCBP may create an Executive Committee and Technical Working Groups as it deems necessary and appropriate.

4.4 Meetings of the NCBP . The NCBP shall meet regularly as it deems fit and shall formulate its standards for making decisions.

4.5 NCBP Secretariat. The NCBP shall create a Secretariat that shall be based in the DOST. All other concerned agencies may be called upon to participate in the functions of the Secretariat.

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:

4.6.1 Biosafety Policy Functions

4.6.1.1 Assist concerned departments and agencies in formulating, reviewing, or amending their respective policies, measures and guidelines on biosafety;

4.6.1.2 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;

4.6.1.5 Issue detailed guidelines on the conduct of socio-economic impact evaluation of biosafety decisions; and,

4.6.1.6 Propose to Congress necessary and appropriate legislation.

4.6.2 Accountability Functions

4.6.2.1 Monitor the implementation of the NBF by concerned departments and agencies;

4.6.2.2 Ensure coordination among competent national authorities that have shared mandates;

4.6.2.3 Ensure that NCBP guidelines, and the principles and processes established in this Framework are complied with by concerned departments and agencies; and,

4.6.2.4 Review procedures for accountability in biosafety decision-making by competent national authorities, with particular emphasis on ensuring independence and impartiality in such decisions.

4.6.3 Scientific Functions

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;

4.6.3.2 Identify and evaluate potential hazards involved in modern biotechnological experiments or the introduction of regulated articles and recommend measures to minimize risks;

4.6.3.3 Recommend the development and promotion of research programs to establish risk assessment protocols and assessment of long-term environmental effects of regulated articles;

4.6.3.4 Develop working arrangements with the government quarantine services and institutions in the evaluation, monitoring, and review of projects vis-à-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;

4.6.3.6 Assist other agencies in developing risk assessment guidelines and procedures of regulated articles for field trials and commercial release;

4.6.3.7 Review the appointment of the members of the Institutional Biosafety Committees created by institutions engaged in activities involving regulated articles, upon recommendation by their respective heads of institutions;

by their respective heads of institutions;

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,

4.6.3.10 Perform such functions as may be requested by concerned departments and agencies.

4.6.4 Capacity Building Functions

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.

4.7 Mandate of the Department of Science and Technology . The Department of Science and Technology (DOST), as the premiere science and technology body in the country, shall take the lead in ensuring that the best available science is utilized and applied in adopting biosafety policies, measures and guidelines, and in making biosafety decisions. The DOST shall 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. 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, it shall exercise such jurisdiction and other powers that it has been conferred with under existing laws. It shall also take the lead in evaluating and monitoring regulated articles intended for contained use.

4.8 Mandate of the Department of Agriculture . As the principal agency of the Philippine government responsible for the promotion of agricultural development growth, rural development so as to ensure food security and contribute to poverty alleviation, the Department of Agriculture shall take the lead in addressing biosafety issues related to the country’s agricultural productivity and food security. 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, it shall exercise such jurisdiction and other powers that it has been conferred with under existing laws. It shall also 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.

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.

4.10 Mandate of the Department of Health . The Department of Health (DOH), as the principal authority on health, shall formulate guidelines in assessing the health impacts posed by modern biotechnology and its applications. The DOH shall also require, review and evaluate results of environmental health impact assessments related to modern biotechnology and its applications. In coordination with other concerned departments and agencies, it shall exercise such jurisdiction and other powers that it has been conferred with under existing laws. It shall also take the lead in evaluating and monitoring processed food derived from or containing genetically modified organisms.

4.11 Mandate of Associated Departments and Agencies . 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, all other departments and agencies shall exercise such jurisdiction and other powers that it has been conferred with under existing laws. In particular, the following departments and agencies shall participate in biosafety decision making, where appropriate: the Department of Foreign Affairs in promoting and protecting Philippine interests on biosafety in bilateral, regional and multilateral forums; the Department of Trade and Industry in relation to biosafety decisions which have an impact on trade, intellectual property rights, investments and consumer welfare and protection; the National Commission on Indigenous Peoples in relation to biosafety decisions which have a specific impact on indigenous peoples and communities; and the Department of Interior and Local Government, in relation to biosafety decisions which have an impact on the autonomy of local government units.

4.12 Focal Point and Competent National Authorities.

4.12.1 For purposes of Article 19 of the Cartagena Protocol on Biosafety, the national focal point responsible for liaison with the Secretariat shall be the Department of Foreign Affairs. The competent national authorities, responsible for performing the administrative functions required by the Protocol, shall be, depending on the particular genetically modified organisms in question, the following:

4.12.1.1 The Department of Agriculture, for biosafety decisions, when covered by the Protocol, concerning plants and plant products derived from modern biotechnology, fisheries and other aquatic resources, domesticated animals and biological products used for animal husbandry or veterinary purposes and biological agents used for biocontrol;

4.12.1.2 The Department of Science and Technology, for biosafety decisions concerning research and development, when covered by the Protocol;

4.12.1.3 The Department of Health, for biosafety decisions concerning pharmaceuticals for humans that are not explicitly excluded under Article 5 of the Protocol, i.e. pharmaceuticals which are not addressed by other relevant international agreements or organizations; and,

4.12.1.4 The Department of Environment and Natural Resources, for biosafety decisions covered by the Protocol that concern regulated organisms intended for bioremediation, the improvement of forest genetic resources, and wildlife genetic resources, and applications of modern biotechnology with potential impact on the conservation and sustainable use of biodiversity.

sustainable use of biodiversity.

4.12.2 The national focal point and the competent authorities listed above shall, as appropriate, coordinate with the NCBP in accordance with its mandate under Section 4.1. For genetically modified organisms not falling under the jurisdiction of the competent authorities enumerated above, the NCBP shall designate the appropriate agency that shall act as such authority.

4.13 Biosafety Clearing House. Concerned government departments and agencies shall utilize the Biosafety Clearing House (BCH) of the Cartagena Protocol on Biosafety in developing and adopting biosafety policies, guidelines, and measures and in making biosafety decisions. The NCBP Secretariat shall serve as the focal point for the BCH in coordination with the DENR-PAWB serving as the focal point for the Clearing House Mechanism (CHM) of the Convention on Biological Diversity.

4.14 Role of Stakeholders and the Public. The role of relevant stakeholders and the public in biosafety decisions is provided for in Sections 6 and 7 of this Framework.

SECTION 5. DECISION-MAKING PROCESSES

Biosafety decisions shall be made in accordance with existing laws and the following guidelines:

5.1 Standard of Precaution. In accordance with Article 10 (par. 6) and Article 11 (par. 8) of the Cartagena Protocol on Biosafety, lack of scientific certainty or consensus due to insufficient relevant scientific information and knowledge regarding the extent of the potential adverse effects of a genetically modified organism on the environment, particularly on the conservation and sustainable use of biological diversity, and on human health, shall not prevent concerned government departments and agencies from taking the appropriate decision to avoid or minimize such potential adverse effects. In such cases, concerned government department and agencies shall take the necessary action to protect public interest and welfare.

5.2 Risk Assessment. Risk assessment (RA) shall be mandatory and central in making biosafety decisions. It shall identify and evaluate the risks to human health and the environment, and if applicable, to animal health.

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:

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.

5.2.2 Risk Assessment Guidelines. The conduct of RA by concerned departments and agencies shall be in accordance with the policies and standards on RA issued by the NCBP. Annex III of the Cartagena Protocol shall also guide RA. As appropriate, such department and agencies may issue their own respective administrative issuances establishing the appropriate RA under their particular jurisdictions.

5.3 Role of Environmental Impact Assessment. The application of the EIA System to biosafety decisions shall be determined by concerned departments and agencies subject to the requirements of law and the standards set by the NCBP. Where applicable and under the coordination of the NCBP, concerned departments and agencies shall issue joint guidelines on the matter.

5.4 Socio-economic, Ethical, Cultural and Other Considerations. Consistent with Article 26 of the Cartagena Protocol, concerned government departments and agencies may take into account socio-economic considerations arising from the impact of regulated articles on the conservation and sustainable use of biological diversity, especially with regard to the value of biological diversity to indigenous and local communities.

The NCBP shall issue guidelines consistent with internationally accepted standards relating to the conduct of social, economic, ethical, cultural and other assessments, as appropriate, prior to decisions to commercialize products of modern biotechnology.

These assessments shall be conducted separately from risk assessment and in a transparent, participatory and rigorous manner.

5.5 Decisions under the Cartagena Protocol. For decisions required under the Cartagena Protocol on Biosafety, the competent national authorities identified may choose to adopt the procedures of the Advance Informed Agreement as provided in Articles 7, 8, 9, 10, 11, 12 and 13 of the Protocol or issue their own respective rules and regulations provided that such rules and regulations are consistent with the Protocol. In all cases, decisions under this Framework shall fall within those timeframes required

the Protocol. In all cases, decisions under this Framework shall fall within those timeframes required

under the Cartagena Protocol. As provided however in the Protocol, failure to comply with such timeframes shall not imply consent to an intentional transboundary movement of genetically modified organisms covered under the Protocol.

5.6 Monitoring and Enforcement. All concerned departments and agencies shall monitor compliance to the conditions attached to approvals and authorizations, especially on risk management, in a manner that is transparent, and in coordination with other agencies, including LGUs, and other stakeholders.

It shall also include monitoring for impacts, whether anticipated or not, of the introduced product on environment and health.

SECTION 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:

6.1 Information on Applications. Concerned departments and agencies shall, subject to reasonable limitations to protect confidential information as provided below, disclose all information on such applications in a prompt and timely manner. Such departments and agencies may require applicants to provide the information directly to concerned stakeholders.

6.2 Confidential Information. In all applications for approvals, whether domestic or foreign, concerned departments and agencies shall ensure that it has procedures and regulations to determine and protect confidential information; Provided, however, that the concerned agencies may refuse declaring the confidentiality of such information if it is necessary to enable the concerned stakeholders to effectively conduct a scientific risk assessment.

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.

6.4 Information on Risk Management, Product Monitoring, and Product Identification. All relevant stakeholders shall have access to information related to risk management and product monitoring. Information on product identification shall be provided to the general public.

SECTION 7. PUBLIC PARTICIPATION

The concerned government departments and agencies, in developing and adopting biosafety policies, guidelines and measures and in making biosafety decisions, shall promote, facilitate, and conduct public awareness, education, meaningful, responsible, and accountable participation. They shall incorporate into their respective administrative issuances and processes best practices and mechanisms on public participation in accordance with the following guidelines:

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:

7.2.1 Notice to all concerned stakeholders, in a language understood by them and through media to which they have access. Such notice must be adequate, timely, and effective and posted prominently in public places in the areas affected, and in the case of commercial releases, in the national print media. In all cases, such notices must be posted electronically in the internet;

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,

7.2.5 Consideration of public concerns in the decision-making phase following consultation and submission of written comments. Public concerns as reflected through the procedures for public participation shall be considered in making the decision. The public shall be informed of the final decision promptly, have access to the decision, and shall be provided with the reasons and

decision promptly, have access to the decision, and shall be provided with the reasons and

considerations resulting in the decision, upon request.

SECTION 8. CAPACITY BUILDING AND FINANCIAL RESOURCES

Implementing the NBF requires the design, adoption and implementation of a capacity-building program supported by adequate financial resources. The following considerations shall be taken into account in developing such a program:

8.1 Need for Capacity Building. To ensure the proper implementation of the NBF, the capacities of various sectors: policy-makers, regulatory agencies, local government units, research community and the general public involved in performing various tasks shall be strengthened;

(a) Policy makers shall be made aware of issues and provided with sufficient and most current information on biosafety for the enactment of appropriate policies, regulations and programs;

(b) Expertise and appropriate facilities in regulatory agencies shall be developed for the safety assessment of regulated articles, harmonization of regulatory policies and procedures and monitoring compliance and outcomes to biosafety regulations;

(c) The research community shall be supported to enable them to address the safety issues of regulated articles; and,

(d) The general public shall be made aware of issues, provided with the correct information and enabled to participate in the biosafety decision-making process. The capacity of environmental and developmental non-government organizations, people’s organizations, professional organizations, including industry and other concerned entities to assist in this capacity-building program shall be enhanced. Agencies involved in implementing the NBF should undertake programs to achieve the above objectives.

8.2 Areas for Capacity Building. Capacity building in all areas relevant to biosafety and biosafety-decision making is necessary, and particularly in the following: in conducting risk assessment; in undertaking social, economic, cultural, ethical and other assessments; and, in implementing transparent and effective public participation procedures.

8.3 Designing and Implementing a Capacity-Building Program. In coordination with other concerned government department and agencies, and with the participation of all relevant stakeholders, the NCBP shall take the lead in developing and implementing multi-agency and multi-sector capacity-building programs that are needed for the effective implementation of the NBF. The basis of such programs shall be a capability needs assessment undertaken by each concerned department and agency and by the relevant stakeholders.

8.4 Financial Resources. The DOST, DENR, DA, and DOH shall allocate from their present budgets such amount as may be necessary to implement the NBF, including to support the operations of the NCBP and its Secretariat. Thereafter, the funding requirements shall be included in the General Appropriations Bill submitted to Congress.

These concerned departments, on an annual or other periodic basis, shall enter into agreement on the sharing of financial and technical resource to support the NCBP and its Secretariat.

SECTION 9. REMEDIES

In cases of violations of laws, rules, and regulations related to biosafety, the following remedies shall apply:

9.1 Administrative Remedies. The concerned departments and agencies shall ensure, in accordance with law, that the right of appeal and other administrative remedies are available to applicants and relevant stakeholders in biosafety decisions.

9.2 Criminal Liability. Natural or juridical persons committing offenses in violation of existing laws shall be prosecuted and penalized in accordance with such laws.

9.3 Civil Liability. Philippine laws on liability and compensation for damages resulting injuries committed on persons shall apply in accordance with such laws.

9.4 International Law. International legal norms on liability and compensation, including those developed and adopted under the Cartagena Protocol on Biosafety, shall likewise apply.

SECTION 10. REVIEW

The NBF shall be reviewed periodically to identify gaps and lessons learned from its implementation and to incorporate new information that may lead to its improvement. The NCBP shall initiate and lead such review every five years from effectivity date of this Order, unless in its determination circumstances, such as emergencies or new developments in science and technology, require an earlier review.

10.1 Review Process. The review shall be initiated by the NCBP and shall involve concerned departments and agencies. Public consultations, in accordance with Section 6, shall be undertaken whenever substantive changes are proposed to the Framework.

10.2 Process of Delisting. Delisting of regulated articles shall rest on the regulatory agencies, subject to guidelines set under the NCBP process. The NCBP shall initiate a study on the feasibility of a delisting procedure for regulated articles.

10.3 Legislation. Lessons learned from implementing the Framework shall be documented and, at an appropriate time, conveyed to Congress for purposes of developing, drafting and adopting legislation on biosafety.

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The Biosafety Regulatory Approach and Governance Mechanism of GM Crops in the Philippines

2019, Iapa Proceedings Conference

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