Global Gene Editing Regulation Tracker https://crispr-gene-editing-regs-tracker.geneticliteracyproject.org Just the Facts Thu, 04 Jun 2020 17:18:10 +0000 en-US hourly 1 https://wordpress.org/?v=5.5 https://crispr-gene-editing-regs-tracker.geneticliteracyproject.org/wp-content/uploads/2019/12/cropped-Global-Gene-Editing-Regulation-Tracker-Darker-Favicon-32x32.png Global Gene Editing Regulation Tracker https://crispr-gene-editing-regs-tracker.geneticliteracyproject.org 32 32 172125604 Ecuador: Germline / Embryonic https://crispr-gene-editing-regs-tracker.geneticliteracyproject.org/ecuador-germline-embryonic/ Thu, 04 Jun 2020 16:56:59 +0000 https://crispr-gene-editing-regs-tracker.geneticliteracyproject.org/?p=8818 No information at this time.

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Ecuador: Gene Drives https://crispr-gene-editing-regs-tracker.geneticliteracyproject.org/ecuador-gene-drives/ Thu, 04 Jun 2020 16:56:37 +0000 https://crispr-gene-editing-regs-tracker.geneticliteracyproject.org/?p=8816 No information at this time.

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Ecuador: Therapeutic / Stem Cell https://crispr-gene-editing-regs-tracker.geneticliteracyproject.org/ecuador-therapeutic-stem-cell/ Thu, 04 Jun 2020 16:56:16 +0000 https://crispr-gene-editing-regs-tracker.geneticliteracyproject.org/?p=8817 No information at this time.

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Ecuador: Crops / Food https://crispr-gene-editing-regs-tracker.geneticliteracyproject.org/ecuador-crops-food/ Thu, 04 Jun 2020 16:55:40 +0000 https://crispr-gene-editing-regs-tracker.geneticliteracyproject.org/?p=8819 Gene-edited crops that do not contain DNA from another species are regulated as conventionally-bred plants unless they contain foreign DNA. The regulation is based on the Organic Code of the Environment, issued in 2019, that established exemptions from very restrictive GMO regulations. Ecuador’s constitution prohibits the commercial cultivation of genetically modified crops, but the import …

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Gene-edited crops that do not contain DNA from another species are regulated as conventionally-bred plants unless they contain foreign DNA. The regulation is based on the Organic Code of the Environment, issued in 2019, that established exemptions from very restrictive GMO regulations.

Ecuador’s constitution prohibits the commercial cultivation of genetically modified crops, but the import of genetically modified food is permitted as long as they are labelled. Other than labeling, there are no regulatory requirements for genetically engineered ingredients. The cultivation of GMO crops is allowed for research purposes only. The Ministry of Agriculture and Livestock regulates genetically engineered crops through the National Agrarian Authority.

Products/Research

None

Regulatory Timeline

2019: Decree 752, Organic Code of the Environment, establishes product-based regulatory framework for “genetically improved organisms” and decides that organisms without foreign genes in the final product are exempt from risk assessment.

2017: Organic Code of the Environment states that regulations for modern biotechnology will focus on conservation and sustainability.

2017: National Assembly of Ecuador approved the Organic Law of Agrobiodiversity, Seeds and Promotion of Agriculture, which approved the entry of GMO seeds into the country for non-commercial research purposes. It also outlined guidelines to “control the illegal use of seeds and transgenic crops”.  This facilitated the work of local scientists working on developing disease-resistant GM bananas.

2010: Organic Law of the Food Sovereignty Regime requires labeling of GM foods.

2008: Article 401 of Constitution of Ecuador declares country free of transgenic crops and seeds, except when supported by the President and approved by the National Assembly.

2003: Cartagena Protocol (an international agreement) ratified, which protects the transport and use of organisms modified by biotechnology.

NGO Reaction

Environmental advocacy groups, including Acción Ecológica, GM Free Latin America and the AgroEcology Fund, are active detractors of biotechnology in Ecuador. The AgroEcology Fund is working with provinces and municipalities to declare ‘GMO free zones’. In 2019, a judge in Quevedo, Ecuador issued a protection order to decommission, eliminate and burn all GM crops in Ecuador in response to a lawsuit filed by two advocacy groups supported peasant organizations. Acción Ecológica said it will maintain its vigilance in preventing new GM cultivations in the country.

Additional Resources

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Ecuador: Animals https://crispr-gene-editing-regs-tracker.geneticliteracyproject.org/ecuador-animals/ Thu, 04 Jun 2020 16:52:46 +0000 https://crispr-gene-editing-regs-tracker.geneticliteracyproject.org/?p=8820 No information at this time.

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Colombia: Crops / Food https://crispr-gene-editing-regs-tracker.geneticliteracyproject.org/colombia-crops-food/ https://crispr-gene-editing-regs-tracker.geneticliteracyproject.org/colombia-crops-food/#respond Sat, 21 Mar 2020 03:07:38 +0000 https://crispr-gene-editing-regs-tracker.geneticliteracyproject.org/?p=8569 Gene-edited crops and food are regulated as conventionally-bred plants unless they contain foreign DNA, after a dossier is submitted to determine if they are exempt. In 2018, the Colombian Agricultural Institute (ICA) issued a resolution that established a case-by-case consultation process to determine if a gene-edited product is considered a GMO. The ICA must respond …

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Gene-edited crops and food are regulated as conventionally-bred plants unless they contain foreign DNA, after a dossier is submitted to determine if they are exempt.

In 2018, the Colombian Agricultural Institute (ICA) issued a resolution that established a case-by-case consultation process to determine if a gene-edited product is considered a GMO. The ICA must respond within 60 days whether the organism will be subject to GMO regulations. For a gene-edited crop not to be considered GMO, it must not contain genes from another species that have been introduced through modern biotechnology techniques.

In 2018, Colombia and 12 other nations, including Argentina, Australia, 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. The ministries agreed to avoid obstacles without a scientific basis for the commercialization of products improved by genome editing, exchange information about products’ developments and applicable regulations and explore opportunities for regional harmonization.

Products/Research

  • Disease-resistant rice and cassava: Colombian scientists from the International Center for Tropical Agriculture (CIAT) used CRISPR-Cas9 to create a strain of rice and cassava that is more easily digestible by consumers and disease resistant.
  • Safer cacao: Scientists from CIAT developed cacao varieties that absorb less cadmium, which is a known carcinogen.
  • Plants that can’t cross-pollinate: Scientists from CIAT used gene editing to develop plants with pollen sterility, which could be used to stop gene-edited plants from cross-pollinating with conventional varieties.
  • Grain with extra starch: Scientists from CIAT used gene editing to increase the concentration of amylopectin (a component of starch) in grains.
  • Bacteria-resistant grain: Scientists from CIAT developed grain resistant to a bacterial pathogen.

Regulatory Timeline

2018: Resolution No. 29299 establishes a case-by-case consultation process to determine if a gene-edited product is within the scope of GMO legislation.

2018: Colombia and 12 other nations, including Canada, Australia, 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.”

2006: Resolution 0946 establishes the procedure for the National Biosafety Committee (CTNBio) to process applications of GMOs for agriculture, livestock and fishing.

2002: Cartagena Protocol (an international agreement) ratified, which protects the transport and use of organisms modified by biotechnology.

1962: The Instituto Colombiano Agropecuario (ICA) is created to regulate crops and research, and to facilitate social agrarian reform.

NGO Reaction

None

Additional Resources

 

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Norway: Animals https://crispr-gene-editing-regs-tracker.geneticliteracyproject.org/norway-animals/ https://crispr-gene-editing-regs-tracker.geneticliteracyproject.org/norway-animals/#respond Sat, 21 Mar 2020 03:06:13 +0000 https://crispr-gene-editing-regs-tracker.geneticliteracyproject.org/?p=8567 Norway has a history of fierce opposition to transgenic biotechnology (GMOs) dating to the early 2000s. Proposed regulations state that gene-edited organisms without foreign genes do not fulfill the definition of transgenic GMOs and should be regulated as conventional. In 2018, the Norwegian Biotechnology Advisory Board proposed a tiered regulatory system in which genetic changes …

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Norway has a history of fierce opposition to transgenic biotechnology (GMOs) dating to the early 2000s. Proposed regulations state that gene-edited organisms without foreign genes do not fulfill the definition of transgenic GMOs and should be regulated as conventional. In 2018, the Norwegian Biotechnology Advisory Board proposed a tiered regulatory system in which genetic changes that can arise naturally or can be achieved using conventional breeding methods would be regulated as conventional plants after a notification is submitted to the government. Organisms developed with other within-species genetic changes would require expedited but limited assessment and approval. Genetic changes that cross species barriers (transgenesis) or involve synthetic DNA sequences would require assessment and approval under strict GMO regulations. Although these regulations appear to pave the way for the introduction of gene-edited organisms, the historical, cultural and political suspicion and opposition to biotechnology in general remains among the most intense in Europe, raising questions about whether these relaxed guidelines will lead to any innovation in this sector.

Biotechnology in Norway is regulated by the Ministry of Agriculture, the Ministry of Environment and the Ministry of Health. Genetically engineered organisms are regulated by the Gene Technology Act, one of the world’s strictest, which requires that genetically modified products contribute to sustainable development in order to be approved. The Gene Technology Act prohibits cloning animals, although exemptions may be granted for for cloning as part of basic biological and medical research, but only when the purpose is to find new treatments or to prevent disease in people or animals.

Products

  • Sterile salmon: The Norwegian Institute of Marine Research used CRISPR to produce sterile salmon, which grow more quickly, are less prone to disease and cannot breed if they escape the facilities.

Regulatory Timeline

2018: Norwegian Biotechnology Advisory Board proposes final recommendations for how GMOs and gene-edited organisms should be regulated, including allowing gene-edited organisms to be regulated as conventional as long as a notification is submitted to the government.

2001: Cartagena Protocol (an international agreement) ratified, which protects the transport and use of organisms modified by biotechnology.

1993: Gene Technology Act finalized, which states products should be ethically justified, sustainable and provide societal benefits.

1992: Bioteknologirådet (Biotechnology Council) established. It has since been a consultative body for the government and parliament on both ethical and environmental concerns related to genetically engineered organisms for import. Bioteknologirådet has developed close relationships with anti-biotech activists and has yet to recommend importing even a single genetically engineered organism.

NGO Reaction

The original opposition to biotechnology in Norway was spearheaded by the Norwegian Institute of Gene Ecology (GenØk) whose purported vision is the safe use biotechnology. In 2006, GenØk obtained status from the coalition government as the National Center for Biosecurity. It produced a series of studies purporting to demonstrate the dangers of insect-resistant Bt corn, which was used as a pretext to suspend the cultivation of Bt corn in Europe, leading to widespread criticism by mainstream scientists. GenØk became tied very closely to the Biotechnology Council, even exchanging board members, in effect blocking all innovation in the agricultural biotechnology sector. GenØk has consistently promoted the work of anti-GMO scientists including the discredited findings of French scientist Gilles-Éric Séralini. It also promotes activist documentaries, such as OMG GMO, scathingly criticized by scientists and reviewers.

Many environmental advocacy groups led by a consortium of 18 organizations known as GMO-Nettverket (GMO-Network) are also active detractors of biotechnology in Norway. The organization includes Greenpeace Norway, Friends of the Earth Norway and numerous organic groups The GMO-Network calls for a “precautionary approach to GMOs” and claims they have “adverse effects on the ecological system and cause unacceptable trouble for conventional and organic farming.” Although the group claims that it is “not against GMOs in general,” they maintain there has not been sufficient “research on long-term consequences for the environment and human health”.

Resources

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Norway: Crops / Food https://crispr-gene-editing-regs-tracker.geneticliteracyproject.org/norway-crops-food/ https://crispr-gene-editing-regs-tracker.geneticliteracyproject.org/norway-crops-food/#respond Sat, 21 Mar 2020 03:04:09 +0000 https://crispr-gene-editing-regs-tracker.geneticliteracyproject.org/?p=8563 Norway has a history of fierce opposition to transgenic crop biotechnology (GMOs) dating to the early 2000s. Proposed regulations state that gene-edited crops without foreign genes do not fulfill the definition of transgenic GMOs and should be regulated as conventional crops. In 2018, the Norwegian Biotechnology Advisory Board proposed a tiered regulatory system in which …

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Norway has a history of fierce opposition to transgenic crop biotechnology (GMOs) dating to the early 2000s. Proposed regulations state that gene-edited crops without foreign genes do not fulfill the definition of transgenic GMOs and should be regulated as conventional crops. In 2018, the Norwegian Biotechnology Advisory Board proposed a tiered regulatory system in which genetic changes that can arise naturally or can be achieved using conventional breeding methods would be regulated as conventional plants after a notification is submitted to the government. Crops developed with other within-species genetic changes would require expedited but limited assessment and approval. Genetic changes that cross species barriers (transgenesis) or involve synthetic DNA sequences would require assessment and approval under strict GMO regulations. Although these regulations appear to pave the way for the introduction of gene-edited crops, the historical, cultural and political suspicion and opposition to crop biotechnology in general remains among the most intense in Europe, raising questions about whether these relaxed guidelines will lead to any innovation in this sector.

Biotechnology in Norway is regulated by the Ministry of Agriculture, the Ministry of Environment and the Ministry of Health. The Directorate for Nature Management is responsible for feed and seed and Norwegian Food Safety Authority is responsible for biotech food. Genetically engineered food is regulated by the Matloven Food Act and the Gene Technology Act, one of the world’s strictest, which requires that genetically modified products contribute to sustainable development in order to be approved. 

So far, the Food Safety Authority has not approved any genetically engineered crops in food or feed. It has, however, granted the fishing industry an exemption from GMO-related permit requirements. All products containing GMOs require a label.

Products

None

Regulatory Timeline

2018: Norwegian Biotechnology Advisory Board proposes final recommendations for how GMOs and gene-edited organisms should be regulated, including allowing gene-edited crops to be regulated as conventional as long as a notification is submitted to the government.

2003: Matloven Food Act finalized, which requires GMO food to be labelled.

2001: Cartagena Protocol (an international agreement) ratified, which protects the transport and use of organisms modified by biotechnology.

1993: Gene Technology Act finalized, which states products should be ethically justified, sustainable and provide societal benefits.

1992: Bioteknologirådet (Biotechnology Council) established. It has since been a consultative body for the government and parliament on both ethical and environmental concerns related to genetically engineered crops for import. Bioteknologirådet has developed close relationships with anti-biotech activists and has yet to recommend importing even a single genetically engineered food crop.

NGO Reaction 

The original opposition to crop biotechnology in Norway was spearheaded by the Norwegian Institute of Gene Ecology (GenØk) whose purported vision is the safe use biotechnology. In 2006, GenØk obtained status from the coalition government as the National Center for Biosecurity. It produced a series of studies purporting to demonstrate the dangers of insect-resistant Bt corn, which was used as a pretext to suspend the cultivation of Bt corn in Europe, leading to widespread criticism by mainstream scientists. GenØk became tied very closely to the Biotechnology Council, even exchanging board members, in effect blocking all innovation in the crop biotechnology sector. GenØk has consistently promoted the work of anti-GMO scientists including the discredited findings of French scientist Gilles-Éric Séralini. It also promotes activist documentaries, such as OMG GMO, scathingly criticized by scientists and reviewers.

Many environmental advocacy groups led by a consortium of 18 organizations known as GMO-Nettverket (GMO-Network) are also active detractors of biotechnology in Norway. The organization includes Greenpeace Norway, Friends of the Earth Norway and numerous organic groups The GMO-Network calls for a “precautionary approach to GMOs” and claims they have “adverse effects on the ecological system and cause unacceptable trouble for conventional and organic farming.” Although the group claims that it is “not against GMOs in general,” they maintain there has not been sufficient “research on long-term consequences for the environment and human health”.

 

Resources

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Norway: Germline / Embryonic https://crispr-gene-editing-regs-tracker.geneticliteracyproject.org/norway-germline-embryonic/ https://crispr-gene-editing-regs-tracker.geneticliteracyproject.org/norway-germline-embryonic/#respond Sat, 21 Mar 2020 03:01:49 +0000 https://crispr-gene-editing-regs-tracker.geneticliteracyproject.org/?p=8561 No information at this time.

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Norway: Therapeutic / Stem Cell https://crispr-gene-editing-regs-tracker.geneticliteracyproject.org/norway-therapeutic-stem-cell/ https://crispr-gene-editing-regs-tracker.geneticliteracyproject.org/norway-therapeutic-stem-cell/#respond Sat, 21 Mar 2020 02:58:40 +0000 https://crispr-gene-editing-regs-tracker.geneticliteracyproject.org/?p=8558 No information at this time.

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