The Benefits from GMO Regulatory Harmonization

On May 4^th, 2021, a webinar organized by the International Consortium on Applied Bioeconomy Research (ICABR) and CropLife International was held, focusing on the importance of regulatory harmonization for genetically modified (GM) and genome-edited crops. The webinar drew on experts from Europe, North America and South America, providing participants with insights about the importance of both trans-Atlantic and globally compatible regulatory frameworks.

Reduce regulatory inefficiencies

Post-pandemic economic growth will be crucial for all economies. Renewed investment confidence may take time, therefore, one key economic growth strategy for national governments is to reduce regulatory inefficiencies. The harmonization of regulations has proven crucial to the rapid domestic approval of the various Covid-19 vaccines, illustrating the economic and human health benefits of regulatory harmonization. Food security can similarly benefit, should the will exist to reduce existing barriers.

Despite the global adoption of GM crops for more than 25 years, there continues to be significant differences in import approvals and market labelling policies for GM foods across countries. This creates trade barriers and hampers innovation. Regulatory harmonization and the adoption of the same technical requirements, standards and guidelines for quality, safety and efficacy, would reduce product development costs and timelines. In addition to reducing trade barriers, regulatory harmonization could assist developing countries and public sector developers to more fully participate in a growing market.

European Union GM crop rejection and its challenges

The opening presentation by Matin Qaim from the University of Göttingen in Germany, highlighted the impacts and challenges of the European Union’s decision to place restrictive regulations on GM crops, in spite of the evidence compiled over the past 30 years that the risks from GM crops are no different than the risks from conventionally-bred crops. One major impact of the EU’s rejection to cultivate GM crops is that EU agriculture is less productive than it could be, leading to growing import needs, especially imports of vegetable oil and soybean destined for livestock feed. The EU imports millions of tonnes of palm oil from Southeast Asia and of GM soy from the Americas. The effect of this is that EU imports are responsible for an estimated 16% of tropical deforestation. The most substantial impact pertains to the mitigation of climate change as the EU’s decision to not adopt GM crops results in the release of an additional 33 million tonnes of carbon dioxide than would otherwise have been the case.

Evidence of GM production of insect resistant and herbicide tolerant crops from 25 countries shows that yields increase with both technologies, chemical use declines with insect resistant crops and farm profitability increases under both technologies, while farmer income increased substantially. Qaim also stressed that current food system transformations will be required and that not all challenges have technological solutions, however, many of the challenges can be addressed through increased plant breeding innovations. Importantly, Qaim is optimistic that the EU will gradually shift to allowing genome-edited crops that do not contain foreign DNA to be regulated as conventional varieties, not subject to GMO regulations, based on the April 2021 report by the European Commission.

Regulatory harmonization in the EU is challenged by political barriers and society’s lack of awareness about the actual safety and benefits of GM crops, which hampers international trade. The EU’s regulatory approach may especially hurt technology adoption for reducing food insecurity and poverty reduction in African and Asian countries

Global safety

The second presentation by Laurie Goodwin from CropLife International in Washington, DC, highlighted the complexity of the global regulatory system for the safety assessment of GM crops. This presentation reinforced that food systems are complex and that no one solution works for all challenges. However, investment in plant breeding is an essential component to begin addressing these challenges and to find solutions to the problems that exist.

All GM crops are assessed for risks to human health and the environment, across multiple jurisdictions. In fact, at this point over 2,500 food safety assessments have concluded positively on the safety of GM crops. These assessments have been conducted by regulatory agencies in over 70 countries, throughout the past 25 years.

Regulatory harmonization does not necessarily need to impact domestic sovereignty. For example, if countries are sharing data or relying on data from another country, each country is still able to make final approval decisions based on their own assessment of the data. An important starting point for regulatory harmonization could be to have one international standard on the submission data required for a safety assessment, so that if a GM crop is submitted for approval in more than one country, the same package of data can be used for all submissions. Regulatory harmonization is also often achieved through international trade agreements, but this has not necessarily occurred in the case of regulatory harmonization for GM crops.

One of the key drivers of innovation is predictable, science-based regulatory systems that deliver consistent results in a timely period. When this scenario is not present, new investments in innovative research and development can be delayed within a given country, or the investments will be made in countries with more predictable regulatory systems. Regulatory harmonization would serve to lower the cost of regulation, opening the door to small and medium-sized enterprises to be able to develop and commercialized new GM crops with new beneficial traits. These new GM crops and traits could benefit small landholders in food insecure countries as well as contribute to improving rural development. To do so, GM crop regulations must be risk appropriate. Recent CropLife International publications in the Journal of Regulatory Science that detail what a modernized risk-based safety assessment for GM crops could look like can be found here.

Biosafety framework in developing nations

The third presentation was by Jose Falck-Zepeda from the International Food Policy Research Institute, headquartered in Washington, DC. The aim of his presentation was on progressive biosafety regulations that help address regulatory, policy and legal challenges which restrict the benefits of GM crops and other biotechnologies. The presentation emphasized international and national public sector agricultural research focused on developing countries. Available evidence indicates that regulatory uncertainty, cost of compliance and regulatory delays have a greater impact on small and medium-sized enterprises and public sector developers, than the large multi-national technology development firms accessing new technologies.

To help address these issues, countries such as Ghana, Kenya, Malawi, Uganda and Nigeria have built their regulatory frameworks’ capacity to improve their risk assessment and decision making capacity and thus facilitate the commercialization of safe and valuable GM crops of interest and other developing countries. Many in the global public sector view the value of innovations offered by new plant breeding technologies, such a genome editing, as these offer advantages in terms of improving productivity, enhanced nutrition crops, as well as increasing crop resiliency and adaptability to climate change. Scientists have expressed a preference for product-based regulatory systems, while the realities for many countries require them to comply with the Cartagena Protocol on Biosafety which is largely a product-based approach. Furthermore, countries have expanded decision making to include other considerations such as socioeconomics, liability and redress, benefit sharing and indigenous and local community rights, amongst others.

Innovative risk models are being developed and implemented, including those that pursue tiered approaches to risk assessment. In these approaches, GM or genome-edited varieties that have extensive production and previous risk assessment, would not require additional regulatory oversight, given the levels of knowledge that presently exist. Other innovative approaches include technical/formal convergence and harmonization approaches, data and decision documentation transportability, and regional approaches to regulation. Experience has shown that bilateral and multi-lateral trade agreements may be able to coordinate the harmonization of technical aspects of regulation and regional approaches to regulation. Data and decision documentation transportability can facilitate harmonization. Pursuing these approaches, risk assessment data gathered from field trials, food/feed safety assessments and/or decision making documentation done in one country is able to be submitted as part of a risk assessment dossier in another country. As an example, Vietnam and Honduras have relied on risk assessment decisions in other countries as part of their approval process for food/feed for processing and for release to the environment, respectively. Similarly, regional initiatives undertaken in Africa regarding data sharing and risk assessments in the COMESA/ACTESA region are being implemented to help facilitate decision making in the continent. These approaches which improve regulatory and decision making capacity facilitate innovation.

Genome editing regulations in Argentina

The final presentation was by Dalia Lewi with the Argentine Ministry of Agriculture, Livestock and Fisheries, who presented the benefits of regulatory harmonization from the perspective of Argentina. The Argentine government strongly believes that compliance with biosafety regulations is vital to the development of biotechnologies that are socially acceptable. Argentina has a history of being a pioneer in terms of biosafety regulation as in 1991, it began to regulate GM crops and in 2015, to regulate genome-edited crops and other new breeding techniques. This was followed in 2019 by regulations for genome editing use in animals and microbes.

In regard to genome editing regulation, Argentina assesses the final product, not the process used to create the product, to determine whether the product is a GM product or not. If it is not, no further regulatory oversight is required, as it is considered a conventional crop. Under this regulatory framework, genome-edited crop varieties considered regulated as conventional varieties would be eligible for organic or any other crop production. So far, 21 consultations have taken place between regulators and developers. These consultations are providing more predictability for the developers and the rapid commercialization of new technologies. The Argentine model for regulation for genome editing has been used by Brazil, Colombia, Chile, Paraguay and Honduras to develop their own regulatory frameworks, while Kenya and Ethiopia are considering using a similar approach.

The challenges of research

While many of the benefits are increasingly being quantified, some academic disciplines publish research that serves to refute the level of benefits. The challenge with some of these studies is that the data utilized for the study is not based on actual farm level practices, reducing the reliability of the results. In other instances, the models used may not be able to control for specific variables that can bias results. One such study suggested that cotton production increases in India were not due to Bt cotton, but rather to increased use of fertilizer. The problem with this study is that it used district level data and was unable to account for how fertilizer was used at the farm level, as no data was presented that indicated how much fertilizer was being used in the production of cotton. One challenge of doing impact assessments is that no ‘gold standard’ exists, but having farm level data improves the ability to identify correlations that help confirm cause and effect. Farm level data improves the predictability of models used in impact assessments, thus providing policy makers with more detailed insights and observations.

Harmonization of risk assessment regulatory processes is a distinct issue from discussions about the inclusion of socio-economic considerations and the broader social acceptability of innovative agricultural products and technologies. Both are important issues, but they are separate discussions. Transparency is an increasingly important issue about the regulation of GM products and while the industry has made great strides in providing greater transparency, similar improvements from governments and regulatory agencies may contribute to improving public acceptance of these products.

Efficient resource use, such as those involved in increasing global food security and reducing hunger, require all technologies available. Regions or countries that fail to do so, such as the EU, put pressure on other parts of the world to meet their food and feed demands, which means the demands for non-GM products reduce the efficiency potential in these places. Trade is crucial for development and by not being able to adopt and freely trade GM crops and products, this further harms the development of low income countries. The lack of regulatory harmonization for GM products has impacts beyond the agricultural industry as there are adverse effects for innovation investments and trade.

International trade agreements and other agreements too, provide definitions of risk assessment. In particular, the World Trade Organization’s Sanitary and Phytosanitary Agreement and the Technical Barriers to Trade Agreement both provide framing points for risk assessment, such that they are able to contribute to improving both food security and food sovereignty. One of the challenges for the use of the WTO agreements is that in many countries, there is not a clear distinction between science-based risk assessment and politically-based GM crop production approvals. The majority of the GM crop adopting countries have science-based regulatory frameworks and when the distinction between risk and social acceptance is blurred, the commercialization of GM crops has proven difficult. While harmonization of science-based risk assessment processes is possible, it is not possible to harmonize politically-based approval decisions. As impact assessments move from being grounded in scientific data and methodology towards societal impact assessments, there are frequently few, or no, models capable of such assessments and the lack of quality data further compounds the challenge, as the lack of evidence prevents decision making.

Balancing technological advances with traditional knowledge can, at times, be challenging. In some instances, some believe that technological innovations are the result of, or needed for, problems caused by previous technologies. Some suggest that genome editing is simply the latest technology being proposed to deal with previous problems created from over reliance on monoculture and the failure to follow good agronomic practices. However, nature is relentless. Pressure from insects and plant diseases continue and in many instances is expanding, with genome editing being viewed as a potentially significant innovation that is capable of mitigating these problems within changing climatic conditions. In many instances, regulation is so inefficient and costly, that it slows the rate of innovation, thus allowing the constraints against reducing food insecurity to remain in place. More efficient regulation would allow for biotechnology to expand beyond the core group of crops presently being produced.