In December 2019, the Pakistan Biotechnology Information Center (Lahore Chapter) hosted a “National Dialogue on Agricultural Biotechnology for Food Security”, in which experts called for a science-based regulatory landscape for new methods in agricultural biotechnology, including genome editing.
The dialogue also featured demands for the revival of the National Commission on Biotechnology, formed in 2001 but lying dormant for years.
Biosafety Rules and Guidelines (2005) incorporated in the Environment Protection Acts are the major regulatory framework for agricultural biotechnology in the country. However, these rules have been in legislative limbo following the 18th Constitutional Amendment in 2010.
Due to the lack of a viable regulatory landscape, the country is unable to benefit from high-yield and stress-resistant new breeding technologies (NBTs). Researchers across at least 40 biotechnology research centers in the country are using such technologies to develop crop varieties, but, without a regulatory framework for commercial production, this intellectual labor will remain confined to research centers.
A novel solution to a chronic problem
Food security and climate change are interlinked global threats. Environmental shocks such as droughts, floods or bushfires have the potential to alter agricultural produce in a very short time span.
Ranked among the top 10 countries affected by climate change, Pakistan has at least 60 percent of its population facing food insecurity. Experts at the Food and Agriculture Organization (FAO) believe that technological interventions in agriculture will have important benefits in terms of ensuring the sustainability of present-day agricultural practices, promoting adequate nutrition, as well as combating the effects of climate change.
During the course of the 20th century, plant breeding methods were revolutionized by progressive suites of biotechnologies. Agricultural biotechnology involves a number of methods to incorporate beneficial traits in plant species. Over the years, the application of these methods has resulted in improved yields, productivity, pest and disease control and climatic adaptability, as well as reduced water requirements and costs.
With rapid transformation since its inception in the 70s, the science of biotechnology has now ushered in the age of ‘genome editing’.
In a nutshell, genome editing (GE) involves techniques through which highly targeted changes can be made in the genomes of living organisms. This has crucial applications in agriculture, allowing scientists to precisely edit plant genomes and generate beneficial crop traits to address food security and climate change challenges. The commonplace analogy for GE is that of a word processor with features such as cut/copy/edit. GE techniques involve specialized enzymes which can insert, replace or remove DNA from a genome with a high degree of specificity. One such method is Clustered Regularly Interspaced Short Palindrome Repeats (CRISPR/ Cas9), known for its precision and cost/time efficiency.
In contrast, New Breeding Technologies (NBTs) are methods that allow plant breeding scientists, industry and farmers to rapidly develop new plant varieties in a precise manner as compared to conventional breeding techniques.
Before GE, genetic modification or genetic engineering was biotechnology’s best platform for introducing novel traits in plants. Using different delivery methods, scientists were able to either add new genes or make changes to already existing genes. A well-known example of such a modification is ‘Golden Rice’, in which rice is modified to produce a precursor of Vitamin A, targeting vitamin-deficient populations such as in the Philippines and Australia. Another common example is that of insect-resistance trait crops such as Bt (an insecticidal protein from Bacillus thuringiensis) cotton. Insects which ingest the modified plants are killed, thus reducing pest attacks and overreliance on broad spectrum insecticides.
Solving the food security challenge
The modern agriculture value chain is quite complex. In developing countries, the focus has been on increasing productivity through soil and water optimization, postharvest management, machinery and storage facilities. The main drawbacks of this approach have been that it is reliant on natural endowments and is not feasible for small farms. As arable land declines worldwide, increasing crop yield through conventional methods has plateaued in several countries and the food security challenge has exacerbated.
Consider Pakistan’s agriculture sector which contributes more than 20 percent of the gross domestic product (GDP) and is based on one of the world’s largest irrigation systems. It has been shown that there is a positive correlation between GDP increase and the output of wheat, rice and cotton growth in Pakistan. However, due to a combination of increasing climatic threats and mismanagement of water reservoirs, traditional practices are becoming endangered. Another problem pertains to the inclination towards using synthetic chemicals for pest control, contributing to various environmental hazards.
Pakistan’s food security woes are linked to limited economic access to an adequate and diverse diet. The present agrarian model is predominantly an extension of the green revolution, in which yields were enhanced through synthetic inputs (fertilizers and pesticides) and modern irrigation practices. Several countries have moved away from the green revolution towards the ‘gene’ revolution. However, the rate of technology adoption in Pakistan’s agricultural system has traditionally been low, the sole exception being the use of biotechnology to grow Bt Cotton.
The NBTs have a significant advantage in allowing farmers to achieve the same rates of productivity as previous techniques of genetic modification without transferring new genes from different species. From a developing country’s perspective, NBTs are cheaper and faster, and will therefore prove to be relatively easier to adopt in laboratories. This also means that there is no chance of monopolization by a select group of multinationals, thus offering huge business potential for small and medium enterprises.
Of all the edits being made through NBTs, changes to the wheat genome that will lead to reduced gluten allergenicity is the one that will most likely prove to be a game-changer.
Developed in Spain, this variant has the potential to reduce the reaction to gluten by 85%, transforming the market for low-gluten foods.
GE approaches have also proved highly successful in the production of high-yield maize and fungal disease-resistant rice varieties. These three crops are integral to the global food chain, and GE has already shown potential to protect agriculture against biotic and abiotic stresses. In addition to cereal crops, NBTs have also been applied to food security plants, such as banana and cassava.
NBTs have allowed scientists to rapidly study the functions of genes in different plant species, thus adding vital information to public databases that can prove highly beneficial to research communities in developing countries. The availability of such large databases signals the private sector to invest, creating opportunities for lucrative public-private partnerships. An example is the Consultative Group on International Agricultural Research, which helps provide plant genetic material to developing countries.
GE livestock can also help to address food insecurity in developing countries by promoting such benefits as the production of high-quality meat, derivatives and disease reduction.
However, all these benefits of GE can only be realized if conducive regulatory approval regimes are in place.
Enter the regulatory imbroglio
Innovations such as biotechnology are subject to regulations and risk assessment owing to the possible harm and uncertainty associated with their use. Since biotechnology applications directly affect public health and the physical environment, institutional frameworks have been put in place to manage risks.
GM crops and agri-biotech products are already being regulated through individually legislated biosafety frameworks in several countries. At the heart of these frameworks are considerations of public health, food and environmental safety or risk assessment. There is no international agreement on ‘regulatory triggers’ to be used for biotech products. The existing regulatory regime comprises two primary triggers, one focused on the process and the other on the product. Process-oriented triggers that regulate the entire production process have been adopted by the European Union (EU), while the United States has chosen to adopt product-oriented triggers that only address the characteristics and traits of the finished product. The rest of the world falls somewhere between either the EU or the US camp.
The primary drawback of process-oriented triggers is that they are too inflexible to accommodate changes in technologies. Additionally, regulating a complete process without focusing on the final product creates unnecessary approval costs for developers. While flexibility is an advantage with the product-oriented trigger, there is limited compatibility for the scope of trade.
This trans-Atlantic divide also has a spill-over effect in international governance setups, including the World Trade Organization (WTO) and the Convention on Biological Diversity (CBD) under which the Cartagena Protocol was negotiated. While the WTO emphasizes science-based risk assessment, the Cartagena Protocol looks at socio-economic considerations. Some critical issues associated with the Cartagena Protocol include a failure to reach consensus on risk assessment, lack of enforcement mechanisms and hindering trade. More importantly, the current legislation has no clear definitional scope for GE, which is incorrectly included under the umbrella of ‘synthetic biology’.
Against this backdrop, agricultural biotechnology experts have been calling for the development of regulatory frameworks that not only cater to existing technologies but also take into account future developments. In a paper on future proofing regulations, Huw D. Jones, a professor of transnational genomics at Aberystwyth University, comments on the need for introducing regulatory mechanisms that are “future proofed by design to be sufficiently agile to address future developments and challenges.”
Policy Considerations for NBTs
Experts agree that over-regulation will inevitably erode the cost-effectiveness of GE, which will hit developing countries the hardest. However, they also caution that, if regulations ‘commensurate with risk’ are not achieved, there is a potential for harm to the environment through unintended effects.
Major legislative challenges in this regard include ambiguities of definitions (what constitutes a genetically modified organism), inconsistent coverage of products, lack of suitable criteria, and variability of applications provided by genome editing/NBTs.
Also important to note is that GE can be done at different levels of the nuclease, known as site-directed nuclease (SDN) applications. This variability further emboldens the argument that the existing regulations are not fit-for-purpose. Crops that are edited for example, using the SDN-1 approach cannot be differentiated from a naturally occurring plant, raising the question: why do we need the regulation?
Argentina and Brazil have become the first two countries to opt for supplementary legislation for NBTs. Within their regulatory setup, NBTs that do not have a new combination of genetic material are exempt from regulation. Canada has currently initiated a policy review involving consultation and feedback. The US has continued its application of the product-oriented trigger for NBTs, while Australia has legislated existing regulations to exclude SDN-1 based editing.
However, following the precautionary principle, the EU has passed a ruling regulating all forms of NBTs as GMOs. The verdict has been met with dismay by experts, who say it will have a ‘chilling effect’ on the development of plant biotechnology.
Where does the public fit in?
Science communication, in general, functions on the ‘deficit model.’ It assumes that the public needs more information on a specific technology, or a scientific discovery, to support it, attributing an adverse perception to the lack of information and understanding. The model works on a flow of knowledge transfer from experts to the public. Unfortunately, this model has not worked well for promoting a positive perception of agricultural biotechnology among the general public. For starters, it reduces the public to mere consumers of products. In a world of fake news and elaborate disinformation campaigns, scientific communication on biotechnology requires a major overhaul. This means that it won’t be enough to just provide basic facts to the public. Experts will also have to provide justifications for adoption of biotechnology, and address major concerns about public health and environment.
As an alternative model, negotiation simulations have been tested by researchers at Murdoch University, particularly with reference to public communications on global problems including climate change and food security. These simulations are focused on role play, borrowing from diplomatic training, and providing an appreciation of the complexity of science policy. One of the simulations featured transdisciplinary participants negotiating the Cartagena Protocol on Biosafety to amend regulations on GE. The pre-and post-simulation surveys indicated that the audience was able to understand subtleties better.
Science and technology do not exist in a vacuum, and public opinion is a major trajectory shaper in the field of agricultural biotechnology. Unfortunately, the current discourse on the issue is polarised and plagued by misinformation. Media coverage is often imbalanced and selective. Many documentaries on the theme have either categorically overlooked scientific data or have resorted to fear-mongering, with monikers like ‘Frankenfoods’ misleading the public. The recent Netflix docuseries ‘Unnatural Selection’ did not do justice to the broad contours of genome editing, since none of the episodes dealt with the application of GE in agriculture. Such selective coverage conditions the audience to a limited understanding of complex technologies. As science would have it, the ‘organic’ and ‘genetically modified’ binary has little definitional consistency, with its origins lying in a sociological framing of biotechnology products. Achieving a balance between an interpretation of scientific data and perception of risks and consumer sentiments is crucial for an inclusive regulatory framework for GE. The problem with an advocacy approach is that it assumes environmental and health risks instead of assessing them. Thus, advocacy groups are already labelling GE in the same vein as GM, which is scientifically wrong.
GE and other NBTs present a remarkable new potential to enhance crop productivity, quality and affordability. The main considerations and challenges in their adoption concern regulatory pathways, cost and consumer perceptions. Some level of international harmonization of regulation will be indispensable to distributing the benefits equitably, benefiting the consumers as well as the environment.
Muhammad Adeel is a Career Diplomat with the Ministry of Foreign Affairs, Pakistan, currently completing his doctoral research in agricultural biotechnology at the WA State Agricultural Biotechnology Centre in Perth, Australia.