By: Lilian Srour, Junior Research Associate, PILPG-NL
For thousands of years, humans have selected the plants and animals with the most desirable characteristics to yield the next generations of food and feed. These desirable characteristics came about through naturally occurring variations in the genetic build of those plants and animals. However, in recent years, modern biotechnology techniques, also known as gene technologies, have made it possible to modify the genetic building blocks of living cells and organisms. Essentially, these gene technologies allow for the artificial modification of genetic material to give organisms new characteristics, such as increasing a plant’s resistance to environmental pressures, diseases, or insects. Such organisms are also known as genetically modified organisms (GMOs).
Over the years, as gene editing technologies have become more advanced and widely utilized, states have adopted regulatory frameworks governing GMOs. At present, there is no uniformity in the overall regulatory approaches to gene editing technologies and the sale of GMO foods and feed. A report issued in 2021 by the United Kingdom’s Food Standards Agency has shed light on the diversity of approaches. This blog takes a closer look at the regulatory framework in the European Union (EU) and Australia in relation to GMOs and genetically modified (GM) food and feed, to exemplify the different approaches when it comes to the regulation of GMOs.
The EU
The EU regulatory framework is premised on principles relating to pre-market authorization based on a prior risk assessment, traceability of GMOs through production and distribution chains, and labeling of GMOs on the market. Currently, Directive 2001/18/EC (GMO Directive) regulates the authorization of deliberate, and experimental, releases and the placing of GMOs on the market. This Directive requires a risk assessment of GMOs intended for release into the environment. The authorization procedure for food and feed can be found under a separate Regulation. The European Food Safety Authority (EFSA) is the risk assessment body that ensures that authorizations are only issued when it identifies no risks for health or the environment. In the authorization procedure, the regulatory framework ensures a high level of transparency whereby information on the applications for authorization, supplementary information provided by applicants, and opinions from the risk assessment authorities are made available to the public. The only exception provides for the exclusion of confidential commercial information.
Traceability and labeling requirements ensure that relevant information on GMOs is available for operators and consumers. Labeling of GMOs and traceability of GMOs and GM food and feed is defined and addressed under Regulation No (EC) 1830/2003. Specific requirements for the labeling of GM food and feed are outlined in Regulation (EC) No 1829/2003. These labeling requirements aim to provide consumers, farmers, and other interested parties with the freedom of choice.
In 2018, the European Court of Justice (ECJ) issued its judgment in its Confédération paysanne case (C-528/16). This judgment has come under criticism from many who describe the EU’s regulatory approach as highly restrictive. This is because the ECJ stated that organisms obtained by modern directed mutagenesis techniques are to be considered as GMOs within the meaning of the GMO Directive In other words, the Court decided that under the current GMO regulatory framework, modern techniques and methods for modifying genetic material constitute a modification that does not fall under the mutagenesis exemption.
Briefly, mutagenesis is a technology that allows for making genetic modifications which mimic spontaneous mutations that would occur naturally, despite being the result of human intervention. Generally, this would be considered a genetic modification technique. However, under recital 17 of the GMO Directive - the mutagenesis exemption - the directive does not apply to “organisms obtained through techniques of genetic modification which have conventionally been used in a number of applications” and have “a long safety record.” Thus, this judgment clarified that new genetic modification techniques that allow for targeted mutagenesis (more modern genetic technologies) interventions will not be exempt, as opposed to conventional random methods of mutagenesis which have been relied on in the past. Hence, modifications through these modern techniques will be subject to the stringent requirements of risk assessment and authorization. On the one hand, this judgment has been characterized as a “missed opportunity for agricultural innovation in the EU.” On the other hand, many farmers and environmentalists have welcomed this decision, demonstrating support for the Union’s cautious approach when it comes to GMOs.
Australia
In Australia, the Gene Technology Regulator (the Regulator), an independent statutory office holder, coordinates the regulation of GMOs and ensures compliance with the conditions of any approvals through inspections, monitoring, audits, and investigations. The Regulator is supported by the Office of the Gene Technology Regulator (OGTR) which is part of the Department of Health.
The national regulatory framework for gene technology consists of the Australian Commonwealth Gene Technology Act 2000 and Gene Technology Regulations 2001, and corresponding State and Territory legislation. This framework prohibits the sale of food produced using gene technology or containing ingredients produced using gene technology, unless the food is listed in Schedule 26 of the 1.5.2 Standard of the Australia New Zealand Food Standards Code. The standard also establishes labeling requirements for food produced using gene technology. It requires that a food for sale that is produced using gene technology includes the statement “genetically modified” in conjunction with the name of the GM food. However, unlike within the EU, Standard 1.5.2 does not outline any specific requirements for traceability.
Diverging Approaches
The aforementioned regulatory approaches are similar in many regards. However, more recently, in contrast to the ECJ’s ruling in 2018, Australia has pursued a different approach whereby it has exempted several gene editing techniques from its Gene Technology Regulations 2001. In doing so, Australia has acknowledged that these more modern techniques produce results identical to the products of conventional mutagenesis, and that more modern techniques have comparable safety records. As mentioned before, the ECJ has held the opposite, where no such safety record can be definitively established for more modern gene editing techniques.
Thus, those who hold that mutagenesis and modern gene editing techniques are comparable and have comparable safety records have considered the ECJ’s judgment to be unscientific, particularly in comparison to Australia’s approach. This is because Australia has exempted modern mutagenesis techniques from its regulatory framework, implying that it considered these genetic engineering techniques to be as safe as previously established cultivation methods, whereas the EU has held that this is not the case. Furthermore, this decision has been considered problematic because organisms edited through conventional mutagenesis may be indistinguishable from organisms edited through more modern targeted mutagenesis. Thus, a product may be subject to, or exempt from GMO regulations because of the use of a particular gene editing technology, despite there being no difference in the outcome (i.e. the final result). Seeing that other countries do not regulate such products as GMOs, and as such do not have the same restrictions and requirements, for instance in terms of traceability, this may lead to accidental imports and undermine the enforcement of the GMO regulatory framework in the EU. This is because other countries have exempted GMOs that have been edited with more modern technologies from such restrictions and labeling requirements. Thus, the EU’s approach has come under criticism from many, whereby the European Commission’s scientific advisors have recommended that the EU revise its GMO regulatory framework.
The European Commission has recently published a study on the status of New Genomic Techniques under EU law. In light of its findings, the Commission plans to initiate a policy action on plants produced through modern targeted mutagenesis. This will involve an impact assessment and a public consultation with the aim of achieving “proportionate regulatory oversight” that would ensure high protection of human, animal, and environmental health, whilst allowing for further innovation.
Conclusion
Thus, whilst the regulatory frameworks in the EU and Australia are comparable, their respective approach to GMOs has become more divergent recently. Whilst Australia seems to be loosening its regulations, the EU maintains a more restrictive approach towards GMOs. In light of many calls for the EU to change or update its current regulatory framework, it remains to be seen whether the policy plans initiated by the Commission will lead to an approach similar to Australia, or whether the EU will maintain its current approach.