Enabling Trade in Gene-Edited Produce in Asia and Australasia: The Developing Regulatory Landscape and Future Perspectives

Abstract

Genome- or gene-editing (abbreviated here as 'GEd') presents great opportunities for crop improvement. This is especially so for the countries in the Asia-Pacific region, which is home to more than half of the world's growing population. A brief description of the science of gene-editing is provided with examples of GEd products. For the benefits of GEd technologies to be realized, international policy and regulatory environments must be clarified, otherwise non-tariff trade barriers will result. The status of regulations that relate to GEd crop products in Asian countries and Australasia are described, together with relevant definitions and responsible regulatory bodies. The regulatory landscape is changing rapidly: in some countries, the regulations are clear, in others they are developing, and some countries have yet to develop appropriate policies. There is clearly a need for the harmonization or alignment of GEd regulations in the region: this will promote the path-to-market and enable the benefits of GEd technologies to reach the end-users.

Keywords: Asia; Asia-Pacific; Australasia; Cas9; GEd; biosafety; crops; gene editing; genome editing; harmonization; path-to-market; regulations; science diplomacy; trade.

Figure 1

A summary of the published work on GEd to improve traits of plant/crop species. (A) The number of GEd studies targeting different traits of crop plants. (B) The percentage of GE studies on different species of plants. (C) The frequency of use of five GEd techniques in current plant research. BE and PE indicate base-editing and prime-editing. (D) Countries where GEd of plants has been undertaken. (E) The outcome of GEd type in plant research. (Source: EU-SAGE database; https://www.eu-sage.eu (accessed on 2 July 2022).

Figure 2

An overview of the bodies that administer or provide information or advice to the Gene Technology Regulator in Australia (https://www.ogtr.gov.au/; accessed on 2 July 2022).

Figure 3

A summary of the pathways to the deregulation of SDN-1 GEd products in Australia.

Figure 4

Preferred Australian model for assessing the risk of GEd foods. Option B: Risk-tiering model—where dealings are classified according to their indicative risk (https://www.genetechnology.gov.au/resources/publications/2017-review-consultation-regulation-impact-statement-modernising-and-future-proofing-national-gene-technology-scheme; accessed on 2 July 2022).

Figure 5

Policy decisions for GEd/GM products in Japan by the Food Sanitation Law and Feed Safety Law.

Figure 6

Pathway to the deregulation of GEd products under the Cartegena Law (Environmental Safety) in Japan.

Figure 7

The path to commercialization for GM and GEd crop plants in China.

Figure 8

The regulatory pathway for gene-edited plants in India.

Figure 9

The administrative framework for commercial release of GEd or GM crops in Pakistan.

Figure 10

Decision tree for NBT products from the Ad Hoc Technical Working Group of the National Committee on Biosafety of Philippines (NCBP). * includes insertion using the CRISPR-CAS with Prime Editing; ** not to be confused with Synthetic Biology, which specializes on sequences/genetic elements (e.g., unnatural base pairs) in the genome that are not found in nature (beyond novel combination); *** relates to a largely synthetically assembled genome).

Figure 11

The procedures of the Biosafety Certification of new agricultural products in Indonesia. (The process follows the numbers as indicated, starting at the Ministerial level, proposal reviews by the Biosafety Committee and its Technical Committee, which assesses technical details, make a final assessment and recommendation for approval at the Ministry level, for issuing a certificate for licensing for planting or trade).

Figure 12

The mechanism of assessment of GEd products in Indonesia (* note for hypothetical products, there needs to be supporting data of molecular analysis and phenotype).

Figure 13

The regulatory status for GEd crops in countries in the Asia-Pacific region. It is based on the deregulation of SDN-1 crops (green), with some countries also deregulating SDN-1 and SDN-2 products, as described in the text. Countries with ongoing discussions (yellow) and regulated as GMOs (red). Note that regulation of GEd crops in China is under discussion, but does not use SDN terminology: at present GEd is still under GMO product safety management measures, but with less onerous requirements in the pathway to commercial approval.