Israel has not determined the regulatory status of gene editing in animals. There is no commercial production of GE animals in Israel. Products/Research Female-only mice: Tel Aviv University researchers used CRISPR in 2019 to develop a system in mice that produces more female offspring than males. The goal is to use the system in farm […]
Chile has not determined the regulatory status of gene editing in animals. There is little research and no products in development. Products/Research Disease resistance in salmon: Favet-Inbiogen, a biotechnology company, used CRISPR in 2017 to increase the genetic disease resistance in salmon. Regulatory Timeline None NGO Reaction None Additional Resources Genetic Literacy Project’s FAQ on
Mexico has not determined the regulatory status of gene editing in animals. Gene-edited products are regulated under laws established for transgenic GMOs, which are highly restrictive. There is little research and no products in development. Products/Research None Regulatory Timeline 2016: The Mexican state of Yucatan declares itself “GMO” free zone, including all genetically engineered crops
According to a federal program announced in 2019, some gene editing techniques will be exempt from a 2016 law that banned the cultivation of genetically engineered organisms except for research purposes. The decree establishing the program describes gene editing as equivalent to conventional breeding methods, the view adopted by most of the world except for
Gene-edited organisms are assessed on a case-by-case basis and require notifying the government, which includes information on the editing technique and genes targeted for modification. No safety or environmental assessments are required unless the organism contains foreign DNA, but each time a gene-edited organism is crossed with another conventional or gene-edited organism, a separate notification process must
There are no transgenic or gene-edited animals yet approved for sale in Argentina. Gene edited animals, when developed, will not be subject to regulation as genetically engineered organisms unless they contain foreign DNA. All gene-edited products must be submitted to CONABIA, or otherwise are considered a GMO. Gene-edited animals will be assessed on a case-by-case
Argentina: Animals Read More »
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
View the EU Animals summary for more information.
United Kingdom: Animals Read More »
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
Australia: Animals Read More »
The EU takes a very strict approach to regulating gene-edited animals that effectively favors banning their introduction. In opposition to scientific recommendations, the European Court of Justice (ECJ) ruled in 2018 that gene editing shall be regulated under the 2001 GMO Directive that heavily restricts transgenic organisms created using genes from another species, even though
European Union: Animals Read More »
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.