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Australia: Animals

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Lightly Regulated

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

The Australian government will not regulate the use of gene-editing techniques in plants, animals and human cell lines that do not introduce new genetic material. The April 2019 ruling is considered a “middle ground” between more lenient gene-editing rules in the United States, Brazil and Argentina, which regulates biotechnology based on the product versus the tightly restrictive measures in the European Union, which regulates based on the process.

Gene edited animals 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, Genus, a UK biotechnology company, and researchers at the University of Missouri developed a pig that is resistant to a deadly virus by deleting just a small section of a gene in the pig’s DNA, which disrupts the virus’ ability to attack the pig’s cells.

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, the American company Recombinetics is conducting tests in Australia of a gene edited, hornless cow that was created by cutting the genome at a specific location and then inserting a specific gene sequence (from a breed of cow that is naturally hornless) into the cut genome, to produce a cow without horns. 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.”

No gene edited animals have been approved in Australia.

Products/Research

  • Non-poisonous toad: University of Melbourne developed a cane toad without its lethal toxin.
  • Daughterless carp: Commonwealth Scientific and Industrial Research Organisation (CSIRO) used CRISPR to safely control carp (an invasive fish species) by removing females from populations.
  • Hornless cattle: The US company Recombinetics conducted tests of gene edited, hornless dairy cattle.
  • Heat-resistant cattle: Recombinetics conducted tests of gene edited cattle that can withstand hotter temperatures.
  • Sexed chickens: To avoid culling male chicks, CSIRO used CRISPR to make a marker gene that allows chickens to be separated at the embryo stage so that only females are incubated and grow into chicks.
  • Chicken eggs without allergens: CSIRO and Deakin University investigated gene editing as a means of removing the allergenic properties in egg whites.
  • Daughterless mice: CSIRO developed mice that only have male offspring, to help control the invasive mouse population.
  • Coral research: Stanford, the University of Texas, and the Australian Institute of Marine Science collaborated to study gene editing in coral with the goal of improving coral reef conservation efforts.

Regulatory Timeline

2019: 2019 Amendments to the Gene Technology Regulations 2001 go into effect, with all gene edited animals 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 New Breeding Techniques.   

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 derived from precision biotechnology and similar end products, obtained through other production methods.”

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.

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.

World single states political map

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

Colombia

Norway

Ecuador

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
Lightly Regulated: Some or all types of gene editing are regulated more strictly than conventional agriculture, but not as strictly as transgenic GMOs.
*Determined: No Unique Regulations: Gene-edited crops that do not incorporate DNA from another species are regulated as conventional plants with no additional restrictions.

†Proposed: No Unique Regulations: Decrees under consideration for gene-edited crops that do not incorporate DNA from another species would no require unique regulations beyond current what is imposed on conventional breeding.

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
Paraguay101010
Uruguay666
India666
UK222
Mexico111
EU222
Colombia1015.5

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
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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.