Scientists and regulatory experts discuss the current global regulatory scenario for gene editing during one of the webinars. Photo: ICRISAT

A harmonized regulatory landscape for new breeding technologies need of the hour

Researchers and policy specialists from across the world called for a uniform enabling regulation to use new breeding technologies (NBTs) effectively. They were speaking during the fourth and fifth webinars of One CGIAR Global Webinar Series on Genome Editing in Agriculture.

Scientists and regulatory experts discuss the current global regulatory scenario for gene editing during one of the webinars. Photo: ICRISAT

Scientists and regulatory experts discuss the current global regulatory scenario for gene editing during one of the webinars. Photo: ICRISAT

Regulation and genome-edited plants

Dr Donald Mackenzie, Executive Director at the Institute for International Crop Improvement at Donald Danforth Plant Science Center, US, said that all plant breeding methods can cause unintended effects, some with a higher likelihood than others, but there is no hazard that is unique to methods that move genes between unrelated organisms. “The assessment of risks should be based on the product and not the method by which it is produced,” he said, adding that Canada was the first country where regulation was triggered by the nature of the product.

Dr Mackenzie also briefly discussed the new changes to biotechnology regulation that the US Department of Agriculture’s Animal and Plant Health Inspection Service (APHIS) introduced this year. These changes are popularly referred to as the SECURE rule.

“It makes three important exemptions. Specifically exempted are those gene-edited products that are categorized SDN 1, SDN 2 and those with genes that are known to occur in a plant’s genepool or an allele replacement,” he added. SDNs (site-directed nucleases) are enzymes that cleave DNA. They have also lent their name to the three broad types of gene-editing processes. SDN 1 and SDN 2 edits do not involve foreign DNA while SDN 3 edits involve addition of new genetic material.

Dr Hugo Campos, Research Director at CIP, argued that gene-editing products produced by SDN 1 and SDN 2 edits should not require additional regulatory oversight compared to regular breeding lines. “The mutations in them are identical to either naturally occurring mutations or those that are produced by mutagenesis and are not novel genetic combinations,” he said.

“Only SDN 3 should be regulated as a GMO,” he added while showing a list of about 10 countries that already regulate SDN 1 and SDN 2 gene-edited crops as regular breeding lines. The European Union, however, regulates all gene-edited crops as GMOs (Genetically Modified Organisms).

Dr Judith Chambers, Director, Program for Biosafety Systems (PBS), IFPRI, presented findings from the program’s recent study that analyzed the global genome editing landscape. The exercise had revealed that much of the work in genome editing was still in early stages. The private sector is active and is sharing technologies for public good, and the work in crops, with great diversity, dominates the scene while work in livestock is mainly in the realm of disease control.

The analysis of biosafety laws across countries revealed the differences in definitions of what constitutes a GMO. A narrow definition that some countries like Ethiopia have implemented excludes most gene-editing applications while a broad definition that countries like Ghana have adopted includes most applications. On the other hand, some countries, Nigeria for instance, have definitions that may include genome editing but offer flexibility to design different regulatory pathways,
Dr Chambers said.

“Our recommendation on regulation is to think from a global to a local perspective. What is going to help establish a science-based oversight around this technology? It is going to be very important to facilitate South-South relationships, and to track the international agreements space,” she said.

Presenting country case studies, Dr Agustina Whelan described the first case study of waxy corn obtained by CRISPR-Cas for which non-regulated status has been allotted by the Argentina National Advisory Commission on Agricultural Biosafety, since it does not contain a new combination of genetic material in the final product.

Speaking about regulations in India, Dr Vibha Ahuja, Chief General Manager, Biotech Consortium India Limited, said ‘genetic engineering’ was defined when rules were introduced in 1989 in India. Under the term genetic engineering, all applications including insertion of foreign ‘heritable material’ into a cell, are included.

“No product of gene editing has been commercialized so far but research in its application is underway in healthcare and agriculture,” she said.

Dr Ahuja also informed that working with SDN 1 edits in plants requires Biosafety Level 1 facilities in India while SDN 2 and SDN 3 gene-edited plants would require Biosafety Level 2. Early this year in India, a draft document ‘Regulatory Framework and Guidelines for Risk Assessment of Genome Edited Organisms’ was opened to public comments.

Providing an overview of genome editing regulations in Kenya, Prof Dorington Ogoyi, Chief Executive Officer, Kenya National Biosafety Authority (KNBA), said there is no specific law for gene-editing technologies in Kenya. Four applications of genome-editing projects in plants and two in animals have been approved by KNBA.

“SDN 1 and SDN 2 will not be regulated under the provisions of the Biosafety Act but will need approval from other agencies,” he said. For applications intending to use genome editing, one will have to apply to the NBA that will inform whether the application will be regulated under the Biosafety Act.

Dr Flerida Carino, member of the Department of Science and Technology, Biosafety Committee, Philippines, presented the status of the recently issued national regulations and draft resolution from the committee. The draft resolution is an explicit policy shift – from a process-based risk assessment and regulation to a product-based risk assessment and regulation system. She reiterated, “It’s a huge distance from the original mechanisms or the original approach that we do for risk assessment of products of modern biotechnology.”

Describing the decision tree of regulation, she mentioned that since SDN 1 and SDN 2 category of gene-edited plant products do not have insertion of genes from non-sexually compatible species or any introduction of a gene bred out of the system, they are deemed to have no novel genetic combinations and would be exempted from GM regulations.

Pathways to commercialization

Citing India, Dr Trilochan Mohapatra, Director General, Indian Council of Agricultural Research (ICAR), spoke about how research from public sector research systems reaches the farmers in India. “The Indian breeding system is elaborate and more than 50 different crops important for agriculture are handled. The best material from both private and public sector is compared and then gets notified in the Indian system,” he said.

Dr Mohapatra also informed that the guidelines for gene editing are being finalized in India. In the context of public-private engagement, he said there is scope for public and private institutes, including small and medium enterprises, to collaborate in using new breeding technologies, as they have been doing thus far with existing technologies.

Dr Mark Rosegrant, Research Fellow Emeritus, IFPRI, said that strong enabling policies are needed for genome editing and other agricultural R&D. Even if favorable, weak policies do not create positive outcomes for research. He explained how the political economy can inhibit adoption of new technologies. He called for a policy environment that enables science and innovation through legal framework for resource rights; regulations to encourage scientific inquiry and exchange; and markets and trade regimes that are open, transparent and fair.

Dr Peter Thygesen, Principal Regulatory Scientist, Office of the Gene Technology Regulatory, Australia, and Chair (Elect), OECD Working Group on the Harmonization of Regulatory Oversight in Biotechnology, listed past and current areas of work in biotechnology for his working group that include sorghum, cowpea, cassava and banana. Since 2014, he informed, the group has been sharing information on experiences with risk assessment and regulation of new plant breeding technologies, specifically genome editing.

Giving a ringside view of discussions in multilateral fora, Ms Sarah Lukie, Managing Director for Regulatory and Multilateral Affairs, Plant Biotechnology, at CropLife International, informed that gene editing is a priority within ‘synthetic biology’ for parties to the Convention of Biodiversity, the overarching treaty that has 196 countries as parties to it.

“There is a general agreement in this forum that many types of applications of synthetic biology may be subject to the biosafety protocol,” she said referring to Cartagena Biosafety Protocol that is a subsidiary to the Convention of Biological Diversity (CBD).

Dr Morven McLean, Chief Executive Officer, Agriculture & Food Systems Institute, emphasized that it is important to address regulatory asymmetries as they would affect trade. She said harmonization can be aided by aligning definitions, standardizing information needed to decide if a gene-edited plant will be subject to additional regulation, timelines for making determinations and recognizing decisions made by other countries.

For practitioners and developers of gene-edited products, Dr McLean said, awareness of regulatory landscape and how a product moves through commerce, including exports, is essential. “There is emerging consensus on SDN 1 and SDN 2 but there are some jurisdictions like European Union where gene-edited plants are considered GMO,” she added.

Dr McLean also said that CGIAR, through its centers and large number of partnerships, has a very important role to play in this harmonization.

Dr Ian Barker, who leads the Global Potato Agri-Food System Program at CIP, said that the seed systems for gene-edited crops are likely to evolve and behave as seed systems for existing breeding technologies do. There could, however, be some specific direct and indirect consequences for seed movement, like in labelling for gene-edited crops, in deregulated environments; then they could be very different from existing seed systems, he added.

That notwithstanding, he called for continued investments to improve seed systems, engagement and capacity building to deliver seeds to smallholder farmers to utilize the potential of new breeding technologies.

Stressing the policy position of the American Seed Trade Association (ASTA) on new breeding technologies, Dr Fan-Li Chou, Vice President, Scientific Affairs and Policy, said that plant varieties produced by NBTs should not be differently regulated if they are indistinguishable from varieties produced through earlier breeding methods. She advocated a ‘technology-neutral’ approach for the seed industry keeping in view the needs of farmers, retailers and consumers.

“Consumers want safe and healthy food for their families, and want farmers to grow that food while conserving natural resources and reducing crop inputs,” she said, emphasizing the need for plant breeding and seed production communities to engage with the wider community.

Researchers and policy specialists from across the world called for a uniform enabling regulation to use new breeding technologies (NBTs) effectively. They were speaking during the fourth and fifth webinars of One CGIAR Global Webinar Series on Genome Editing in Agriculture.

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