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China: Animals

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Ongoing Research, Regulations In Development

Gene editing regulations for animals not yet announced; currently strictly regulated as genetically modified organisms.

China does not have a regulatory framework for animal gene editing, but there is extensive research being done. China has published more research papers on CRISPR than any other country. China’s Ministry of Agriculture currently regulates gene-edited animals like genetically modified organisms, which are severely restricted, but many researchers and companies believe China will decide to regulate most gene editing techniques as conventional animals.

China regulates genetically modified organisms through regulations put forth by the Ministry of Agriculture in 2001, called Regulations on Administration of Agricultural Genetically Modified Organisms Safety. China regulates the process used to create genetically modified organisms rather than the characteristics of the final products, as is the case in the US and many other countries, and includes products derived from GMOs under GM legislation.

In 2017, state-owned ChemChina bought Switzerland-based Syngenta, one of the world’s four largest agribusinesses and a company deeply involved in gene-editing research, for $43 billion, the most China has ever spent acquiring a foreign company. In 2019, British livestock genetics firm Genus licensed its patented technique to develop virus-resistant pigs to Beijing Capital Agribusiness (BCA), which will seek regulatory approval for the pigs in China.

Products/Research

  • Virus-resistant chickens: Czech Academy of Sciences researchers developed chickens resistant to a common virus called avian leukosis virus (ALV). A company called Biopharm is now in discussion with poultry producers in China about introducing this change into commercial breeds.
  • Tuberculosis-resistant cows: College of Veterinary Medicine, Northwest A&F University researchers used CRISPR to produce live cows with increased resistance to bovine tuberculosis.
  • Fast-growing monkeys: Researchers at the Yunnan Key Laboratory of Primate Biomedical Research used CRISPR to develop macaque monkeys that age faster than normal.
  • CRISPR research in monkeys: Researchers at the Yunnan Key Laboratory of Primate Biomedical Research and the Chinese Academy of Sciences (CAS) were the first to develop a way to introduce a new gene in monkeys (instead of inactivating or modifying existing genes).
  • Muscular dystrophy research in monkeys: Researchers at the Yunnan Key Laboratory of Primate Biomedical Research used CRISPR to develop a monkey model of muscular dystrophy, a severe muscle disease.
  • Autism research in monkeys: Researchers at the Yunnan Key Laboratory of Primate Biomedical Research used CRISPR to develop a model of autism in monkeys that allows researchers to learn more about the disease.
  • Cancer research in monkeys: Researchers at the Yunnan Key Laboratory of Primate Biomedical Research used CRISPR to learn more about cancer.
  • HIV resistance in monkeys: Researchers at the Yunnan Key Laboratory of Primate Biomedical Research used CRISPR to knock out a gene that makes humans resistant to infection with the most commonly transmitted variant of HIV.
  • Human disease research in pigs: Researchers used CRISPR to introduce a humanized gene into pigs. The gene produces a protein that is given in cases of traumatic shock or liver failure.
  • Hardier pigs: Researchers at CAS used CRISPR to develop pigs that can withstand cold temperatures better and have leaner meat.
  • Fast growing pigs: Researchers at CAS used CRISPR to develop pigs that grow more quickly which will allow farms to produce meat faster.
  • Disease-resistant pigs: Researchers used CRISPR to develop pigs resistant to classical swine fever and porcine reproductive and respiratory syndrome virus.
  • Pig organs for humans: Researchers used CRISPR to study how organs developed in pigs can be used for human transplants.
  • Pigs with more muscle: South Korean researchers and researchers from Yanbian University used a gene editing technique called TALENs to develop pigs that produce more meat. Jilin University researchers also developed indigenous pigs with more muscle.
  • Pigs with less fat: Chinese Academy of Agricultural Science researchers developed pigs with less fat and increased insulin sensitivity, which could be used for future treatment options for human obesity and diabetes.
  • Human organs in monkeys: Researchers used CRISPR to take the first step in growing human organs in monkeys by creating embryos that contained both human and monkey cells.
  • Modified monkeys: Chinese researchers at the Yunnan Key Laboratory of Primate Biomedical Researchwere the first to use CRISPR in monkeys in 2014. They modified three genes: one that regulates metabolism, one that regulates immune cell development and one that regulates stem cells and sex determination.
  • Dogs with more muscle: Researchers used CRISPR for the first time in dogs to knock out a gene that inhibits muscle mass.
  • TB-resistant cows: Researchers used TALENs to increase tuberculosis resistance in cows.
  • Micro-pigs: BGI, a Chinese biotechnology company, used CRISPR to develop extremely small pigs, which may be sold as pets in the future.
  • Goats with more muscle:  Northwest A&F University researchers used CRISPR to develop goats with enhanced body weight and larger muscles.

Regulatory Timeline

2014: Chinese scientists were first to use CRISPR in monkeys.

2001: Regulations on Administration of Agricultural Genetically Modified Organisms Safety published, which heavily regulates the import and domestic production of genetically modified crops.

NGO Reaction

None

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.

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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.

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