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Science Speaks - Blog by ISAAA

The Global GM Regulatory Landscape and How Gene Editing Fits In It (Part 2)

By Zabrina J. Bugnosen
November 12, 2021

Genetically modified (GM) crops have been planted in different countries for 25 years. In an article written by Crystal Turnbull, Morten Lillemo and Trine A. K. Hvoslef-Eide of the Norwegian University of Life Sciences in early 2021, the regulatory approaches and systems of some of the top GM crop-producing countries as well as their experiences were documented and reviewed to come up with an overview of the global legislative landscape. The article highlights the individual country regulations and how gene editing, a newly emerging field of technology with tremendous potential benefits to farmers and consumers, fits in them.

(Part 2 of 2. Read Part 1 to learn about the GM landscapes of Europe, North America, South America and Africa.)

Asia and the Pacific – Diversified regulatory approaches

In 2019, ISAAA reported that nine out of the 29 countries that planted GM crops are from Asia. Two of these, India and China, are the top Bt cotton-producing countries. In the article, only India and China’s GM landscapes are detailed due to their ranks in the numerous countries located in Asia, although the Philippines is briefly mentioned as the only target country to grant approval for Golden Rice for consumption.

India’s Genetic Engineering Approval Committee is in charge of granting approvals to GM crop applicants, or otherwise. As for gene editing, India’s Department of Biotechnology published the proposed guidelines for public consultation. The draft guidelines propose a tiered approach – the more changes there are  to the organism’s DNA, the more assessments it will have to go through. As for China, the country has been a strong promoter of GM crops from the technology’s early days with the intent of ensuring food security while becoming a leader in agricultural biotechnology. True enough, China has also shown strong support for gene editing, having produced a voluminous amount of publications related to CRISPR-Cas (42%), and patent applications for CRISPR-Cas in agriculture (69%) from 2014 to 2017. This comes even as China still does not have a regulatory framework for gene-edited crops for commercial release.

Japan is regarded to have an unusual approach to GM regulations. While the country has the second highest number of GM event approvals for food, feed and cultivation as of 2018, it does not plant GM plants except for the blue rose flower. This is because the country’s legislation requires that cultivation approval only be obtained for imported products intended for food, feed or processing purposes. This allows the Japanese regulators to evaluate environmental risks associated with GM crops just in case  seed mixes happen with conventional, non-GM seeds. In recent years, Japan has made efforts to clarify its regulations. The clarification made by the Japanese Ministry of Environment stated that products that do not contain inserted DNA or RNA are not considered as living modified organisms under the Cartagena Protocol definition. Thus, SDN1-developed organisms are not considered GMOs in Japan.

Likewise, Australia also made clarifications about their own regulations. In 2019, Australia amended the Gene Technology Regulations of 2001 and introduced a new exclusion classifying SDN1 organisms as not GMOs within the definition of the Gene Technology Act of 2000. Thus, an SDN1 crop does not fall within the regulatory guidelines of the Gene Technology Act but instead it is under the regulations of the Department of Agriculture, Water and the Environment. If the crop has products, these are regulated under the Australia New Zealand Food Standards Code.

The way forward for gene editing: Harmonized and science-based mature regulations

The regulatory approach landscape for different countries and regions greatly varies. Based on the evidence obtained by the authors, the countries which are currently on top in terms of cultivation and export of GM crops have regulatory frameworks that are efficient, easy to understand and comply with, and are enforceable. They were also able to determine the trend that the countries that are leading the GM cultivation are the same countries that are quickly adapting their biosafety legislations to the emerging gene editing technology. In past ISAAA events, experts commented multiple times that harmonization of definitions and regulations is a key factor in bringing biotech products faster and closer to its beneficiaries. The article found evidence that countries that have already implemented an authorization process for gene-edited products are on their way to harmonized regulations, as shown by Japan’s and Australia’s treatment on SDN1 products.

Throughout the study, the authors of the article highlighted another important factor when developing harmonized regulations: societal values. The article states that “the law is fundamentally an expression of the values of society. The law commands societal obedience by reflecting and expressing the generally accepted social values.” Furthermore, scientific expertise and analyses play a greater role in today’s society in informing societal values which causes changes to the law. The 25-year experience in scientific, political, and regulatory experiences of the GM technology and adoption are being used as bodies of evidence to further develop and update laws to accommodate gene-edited crops.

The more mature and competent regulatory processes are, the more flexible they can be to provide policy considerations of gene-edited products. Flexible regulations can help avoid the need to evaluate every single procedure that encompasses new breeding techniques. Flexibility allows a case-by-case assessment and discretion in reaching an outcome. It can also lead to the harmonization of strategies while still relying on scientific evidence on new breeding techniques.

In conclusion, the authors reiterated the importance of having a reliable regulatory framework to enforce science-based assessment. They stated that the initial evolution of biosafety law honors the societal values of risk assessment and management with the objective of preserving human, animal and environmental health. Some of these regulations have already matured and have become flexible enough to allow gene-edited products for authorization, and have avoided turning into onerous approaches that hinder the development of scientific expertise and knowledge sharing.

It is important to know the different regulatory approaches of each country that have granted approval to the processing and cultivation of GM crops. It enables the understanding of why these approvals were granted, and how these regulations evolved to reflect the respective country’s societal values. To know more details about country regulations and how these affect the global trade of biotech crops, sign up for ISAAA’s 4th Asian Short Course on Agribiotechnology, Biotechnology Regulation, and Communication (ASCA) which will be held from November 23 to 26, 2021. The event will also tackle science communication and science diplomacy, which are both important in implementing international and local biosafety regulations.

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