A Public Resource Compiled by the

Australia: Crops / Food

Print Friendly, PDF & Email
Australia Flag

Lightly Regulated

One type of crop gene editing de-regulated as conventional plants while the rest are regulated as GMOs, requiring pre-market approval.

Australia has de-regulated one type of gene edited crops. Like Europe, Australia regulates based on the process used to develop gene edited products, instead of the characteristics of the product itself. Gene edited plants are regulated by the Gene Technology Regulator (GTR) under the Gene Technology Regulations 2001. The GTR’s 2019 Amendments state that New Breeding Techniques (NBTs) that cut the genome at a specific location, but do not control or specify what DNA sequence is inserted into the cut (known as SDN-1 techniques) are not regulated because they are more like traditional mutagenesis techniques. For example, Yield10 Biosciences in the US gene edited camelina (a plant in the mustard family that is used for vegetable oil and animal feed) with enhanced omega-3 oil. They did this by cutting a specific gene in the plant, which inactivated the gene and increased the omega-3 content.

This is in contrast to other gene editing techniques that do specify exactly what gene sequences will be inserted (known as SDN-2 and SDN-3 techniques). For example, researchers in the US developed an herbicide-resistant potato by cutting a specific gene of the potato and then inserting a specific sequence of DNA that decreased the herbicide’s effect on the potato. These types of techniques are regulated under existing gene technology legislation, which requires a license. Geneticists James Hereward and Caitlin Curtis of the University of Queensland in Brisbane, describe the Australian ruling as a “‘middle ground‘ between more lenient gene-editing rules in the United States, Brazil and Argentina, and tougher measures in the European Union.”

In 2018, Australia and 12 other nations, including Argentina, Canada, Brazil and the US, issued a joint statement to the World Trade Organization supporting relaxed regulations for gene editing, stating that governments should “avoid arbitrary and unjustifiable distinctions” between crops developed through gene editing and crops developed through conventional breeding.

No gene edited crops have been approved in Australia.

While the Gene Technology Regulator is in charge of laws to protect people and the environment from risks posed by genetically engineered organisms, food is regulated in Australia under a joint system with New Zealand. Food Standards Australia New Zealand (FSANZ) develops and sets pre-market regulations and labeling standards gene edited food. FSANZ will release a final report in 2019 detailing whether NBTs will be regulated as GMOs or whether some gene edited food will not require pre-market approval.

Products/Research

  • High-protein grain: Researchers from the University of Queensland developed sorghum that is larger and has extra protein.
  • Fungus-resistant wheat: Researchers from the Commonwealth Scientific and Industrial Research Organisation (CSIRO) used CRISPR and TALENs to study wheat rust, a common fungus that destroys wheat crops.
  • High-yield wheat: CSIRO used a gene editing technique called RNAi to develop wheat with increased yields, as well as improved quality and tolerance to environmental stressors like heat, cold and drought.
  • Virus-resistant barley: CSIRO used RNAi to develop barley resistant to Barley Yellow Dwarf Virus.
  • Low trans-fat oil: CSIRO used RNAi to develop a cottonseed oil (used in margarine and cooking oils) without trans-fatty acids, making it a healthier oil for human consumption.
  • Improved canola: Researchers at the University of Sydney developed canola with better drought tolerance, photosynthetic capacity and seed oil content.
  • Low-gluten potatoes: Researchers from Murdoch University developed a low gluten index (GI) potato using CRISPR.
  • Sticky rice: Researchers from the University of Queensland used CRISPR to develop sticky rice, a type of rice widely consumed across Asia.

Regulatory Timeline

2019: 2019 Amendments to the Gene Technology Regulations 2001 go into effect, with all gene edited crops regulated except those developed using SDN-1 techniques.

2019: Gene Technology Regulator conducts a technical review of the Gene Technology Regulations 2001 clarifying the regulatory status of organisms developed using a range of NBTs. 

2018: Australia and 12 other nations, including Argentina, Canada, Brazil and the US, issue a joint statement supporting agricultural applications of precision biotechnology, stating that governments should “avoid arbitrary and unjustifiable distinctions between end products (crop traits) derived from precision biotechnology and similar end products, obtained through other production methods.”

2018: FSANZ releases a preliminary report summarizing the various views and possible outcomes for how the Food Standards Code should apply to food derived using New Breeding Techniques (NBTs).

2001: Gene Technology Agreement goes into effect. The Agreement is an inter-governmental agreement regarding the establishment of a nationally consistent regulatory system for gene technology.

2001: Gene Technology Act 2000 begins. The Act is a plan for the regulation of GMOs in Australia and includes the Gene Technology Regulations 2001. The Act defines gene technology as any technique for the modification of genes or other genetic material.

1999: Standard 1.5.2: “Food produced using gene technology” is adopted as a new standard within Food Standards Australia New Zealand.

1991: The Food Standards Australia New Zealand 1991 is developed as a new section of the Australia New Zealand Food Standards Code.

NGO Reaction

Environmental advocacy groups including Gene Ethics, a non-profit against GM technology, argued that the 2019 amendments to the Gene Technology Regulations were “irresponsible and would lead to a ‘free-for-all’ without appropriate boundaries”. The European Network of Scientists for Social and Environmental Responsibility (ENSSER) wrote to Australian senators urging them to disallow the amendments. The Greens Party, an Australian political party, filed the disallowance motion in November of 2019 an attempt to overturn the 2019 amendments, but the motion failed, not receiving enough support.

Additional Resources

Click on a country (eg. Brazil, US) or region (eg. European Union) below to find which agriculture products and processes are approved or in development and their regulatory status. The regulations on genetically engineered crops and animals are emerging out of the regulatory landscape developed for transgenic GMOs.

Hotspots Background

European Union

European Union

Brazil

New Zealand

New Zealand

United States

United States

Australia

Australia

Canada

China

United Kingdom

United Kingdom

Israel

Argentina

Argentina

Japan

Mexico

Russia

Chile

Uruguay

Paraguay

India

Africa

Ukraine

Southeast Asia

Southeast Asia

Central America

Central America

Agriculture Gene Editing Index
Compare Regulatory Restrictions Country-to-Country

Gene editing regulations worldwide are evolving. The Gene Editing Index ratings below represent the current status of gene editing regulations and will be updated as new regulations are passed.

Colors and ratings guide
 

Regulation StatusRating
Determined: No Unique Regulations*10
Lightly Regulated8
Proposed: No Unique Regulations†6
Ongoing Research, Regulations In Development5
Highly Regulated4
Mostly Prohibited2
Limited Research, No Clear Regulations1
Prohibited0
*Gene editing regulated under existing legislation with no unique restrictions, except Argentina, which passed new, flexible regulations.

†Decrees under consideration, but not yet passed, to regulate gene-edited crops or animals as conventional.

Crops/Food:
Gene editing of plants and food products. Research and development has mostly focused on disease resistance, drought resistance, and increasing yield, but more recent advances have produced low trans-fat oils and high-fiber grains.
Animals:
Gene editing of animals, not including animal research for human drugs and therapies. Fewer gene edited animals have been developed than gene edited crops, but scientists have developed hornless and heat-tolerant cattle and fast-growing tilapia may soon be the first gene edited animal to be consumed.

Rating by Country / Region
Click each column header and arrow to sort the countries / regions

Swipe right/left if all columns aren't visible

Country / RegionFood / CropsAnimalsAg Rating
Japan888
Brazil101010
Canada888
Russia555
Argentina101010
Israel1057.5
Australia888
China555
US1047
Chile1015.5
New Zealand444
Ukraine111
Central America666
Paraguay666
Uruguay666
India888
UK222
Mexico111
EU222

Global gene editing regulatory landscape

The regulations on genetically engineered crops and animals are emerging out of the regulatory landscape developed for transgenic GMOs. Regulations across 34 countries where transgenic or gene edited crops and animals are commercially allowed (as of 12/19) are guided in part by two factors:
 
 
Whether the country has ratified the international agreement that took effect in 2003 that aims to ensure the safe handling, transport and use of living modified organisms (LMOs) resulting from biotechnology that may impact biological diversity, also taking into account potential risks to human health. It entered into force for those nations that signed it in 2003. It applies the ‘precautionary approach as contained in the Rio Declaration on Environment and Development. The US, Canada, Australia and Chile and the Russian Federation have not signed the treaty.
 
 
Whether regulations are based on the genetic process used to create the trait (conventional, mutagenesis, transgenesis, gene editing, etc.) or the final product.Transgenic crops and animals (aka GMOs) are product regulated in many countries including the US and Canada, while the EU, India, China and others regulate based on how the product is made. There is almost an equal number of countries with product- and process-based regulations. It’s not clear how much this distinction matters. It’s somewhat true that countries with product-based regulation have more crops approved and the approval process is more streamlined, but there are contradictions. For example, Brazil and Argentina have emerged as GMO super powers using different regulatory concepts, while there is no GMO commercial cultivation in Japan, North Korea, and the Russian Federation, which employ product-based regulations. How this will effect gene editing regulations is also unclear. For example, Japan, which has no commercialized GMOs, is emerging as a leader in the introduction of gene edited crops.
Agricultural Landscape

Gene editing is a set of techniques that can be used to precisely modify the DNA of almost any organism. It is being used for applications in human health, gene drives and agriculture. There are numerous gene-editing tools besides CRISPR-Cas 9, which gets most of the attention because it is a comparatively easy tool to use.

Gene editing does not usually involve transgenics – moving ‘foreign’ genes between species. It also refers to a specific technique in contrast to the general term GMO, which is scientifically ambiguous, as genetic modification is a process not a product. Most gene editing involves creating new products by deleting very small segments of DNA (sometimes in agriculture called Site-Directed Nuclease 1 or SDN-1 techniques), which can silence a gene or change a gene’s activity. Countries are evaluating whether or not to regulate this type of gene editing, since it is so similar to natural mutations. The GLP’s Gene Editing Index ratings reflect the regulatory status of SDN-1 techniques, which are the most liberally regulated and will generate most products in the near term.

To develop different products, gene editing can change larger segments of DNA or add DNA from other species (a form of transgenics sometimes in agriculture called SDN-2 or SDN-3 techniques). While many countries are not regulating or lightly regulating SDN-1 techniques, most are moving toward tightly regulating or even restricting SDN-2 and SDN-3.

For more background on the various gene editing SDN techniques, read background articles here and here.

Send this to a friend