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United States: Gene Drives

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Highly Regulated

Gene drive research is ongoing, but regulations are unclear.

Worldwide, gene drive regulations are in flux. Gene drives are being developed using transgenic technology (GMOs) that contain foreign genes, as well as gene editing, including CRISPR (synthetic gene drives), which do not, complicating regulatory oversight as gene editing and GMOs are often regulated differently.

There is no clear gene drive regulation in the United States. A guidance issued by the Food and Drug Administration (FDA) in 2009 stated that genetically engineered DNA constructs intended to affect the structure and function of an animal, regardless of their use, meet the criteria for veterinary drugs and are regulated as such. Therefore, gene drives would presumably be regulated by this guidance. However, it is unclear exactly how this guidance would apply to gene drives meant to control invasive species and gene drives in insects.

A report completed by the National Academy of Sciences concluded that three agencies will most likely be involved in regulating gene drives: the FDA, the Department of Agriculture (USDA), and the Environmental Protection Agency EPA. However, there are many regulatory overlaps and gaps. For example, gene drives could be regulated by the Federal Insecticide, Fungicide, and Rodenticide Act (enforced by the EPA) because an insect gene drive could function as an insecticide, the Toxic Substances Control Act (enforced by the EPA), and the USDA Animal and Plant Health Inspection Service (APHIS) which protects US agriculture and natural resources. It is unclear which agency or act will take the lead in regulating gene drives. In response to these regulatory gaps, the FDA and USDA both announced plans to update their gene editing regulations.

There are many gene drive research programs underway in the US, but no gene drives have been tested or released outside the lab. Researchers are investigating ways to build-in controls and external overrides into gene drives, so that they can be extinguished if necessary after they have been released. The Defense Advanced Research Projects Agency (the research arm of the Department of Defense; DARPA) is funding most of the research on gene drive safety and control. DARPA published a Safe Genes contract that forbids field testing until more research is completed.

A company called Oxitec, which has field tested genetically engineered mosquitoes in Brazil, Panama and the Cayman Islands, was approved by the Florida Keys Mosquito Control District to conduct a field test, but the proposal was rejected by voters. Oxitec is now trying to get approval for a different Florida test site.

In 2019, researchers from the University of California, San Diego developed a gene drive to address antibiotic resistance, a serious health crisis. Bacterial antibiotic resistance, which could lead to as many as 10 million drug-resistant disease deaths per year by 2050 if left unchecked, develops as antibiotics are prescribed to humans and used in animal food production. It is not easily treatable using antibiotics. The gene drive provides a workaround, inactivating the antibiotic resistance gene in E. coli and creating an amplifying positive feedback loop to ensure no cells survive and develop resistance.

Products/Research

  • Self-limiting moth: Cornell University researchers developed a genetically engineered diamondback moth with a self-limiting gene that prevents female caterpillars from surviving, which could help control moth populations that damage crops. Completed a controlled open-field trial in 2019.
  • Fighting antibiotic resistance: Developed by researchers at the University of California, San Diego (UCSD) using CRISPR in 2019. The gene drive combats antibiotic resistance in E. coli by inactivating an antibiotic resistance gene and creating a positive feedback loop to ensure all cells are affected.
  • Mice with white coats: Developed by researchers at UCSD using CRISPR. This was the first gene drive test in mammals and was for research purposes only.
  • Sterile flies: Developed by researchers at UCSD and University of California, Berkeley using CRISPR as a possible way to control disease-carrying or crop-destroying insects.
  • Dengue-resistant mosquitoes: Developed by researchers at UCSD using CRISPR.
  • Mosquitoes die when infected by any virus: Developed by researchers at USCD using CRISPR.
  • Malaria-resistant mosquitoes: Developed by researchers at UCSD using CRISPR.
  • Flightless mosquitoes: Developed by researchers at the University of California, Irvine using CRISPR to help curb the spread of Dengue fever.

Regulatory Timeline

2019: The USDA-APHIS proposes a new biotechnology regulation, Movement of Certain Genetically Engineered Organisms (also called the SECURE Biotechnology Regulations), which reduces the regulatory requirements for organisms that are unlikely to pose risks to other plants.

2018: The FDA announces its Plant and Animal Biotechnology Innovation Action Plan, pledging to clarify policies on gene editing and ensure developers have a clear path to efficiently bring a product to market.

2017: FDA releases draft guidance suggesting it will regulate gene edited animals as drugs, which involves extensive safety assessments.

2017: OSTP issues an Update to the Coordinated Framework (CF) for the Regulation of Biotechnology, which clarifies the current roles and responsibilities of, and coordination among, FDA, EPA, and the USDA-APHIS.

2016: OSTP issues a National Strategy for Modernizing the Regulatory System for Biotechnology Products, which presents a vision for ensuring that the federal regulatory system is prepared to assess future products of biotechnology.

2015: The Executive Office of the President (EOP) issues a memorandum directing the EPA, FDA and USDA to update the Coordinated Framework for the Regulation of Biotechnology, develop a long-term strategy and commission an expert analysis of the future landscape of biotechnology.

2009: FDA’s Center for Veterinary Medicine (CVM) issues guidance document stating genetically engineered DNA constructs intended to affect the structure and function of an animal, regardless of their use, meet the criteria for veterinary drugs and are regulated as such.

1996: Federal Insecticide, Fungicide, and Rodenticide Act finalized, which is enforced by the EPA. This act would most likely apply to any gene drives that are meant to control insect or rodent populations.

1987: Coordinated Framework for the Regulation of Biotechnology established, outlining the basic federal policy of the agencies (USDA, FDA and EPA) involved with reviewing biotechnology research and products.

1976: Toxic Substances Control Act finalized, which is enforced by the EPA. This act may apply to gene drives that may pose a health risk to humans.

1938: Food, Drug, and Cosmetic Act finalized, which defines a drug as anything “intended to affect the structure [or] function” of an animal.

NGO Reaction

Gene drives face fierce opposition from certain environmental advocacy groups, which claim that modified creatures might spread across borders and adversely impact the environment in unseen ways—claims most scientists say are overblown. The Canadian-based, international organization ETC Group and more than 200 global anti-GMO activists and NGOs published an open letter in 2016 opposing gene drives and called for a global moratorium. During the 2016 World Conservation Congress, a select group of NGOs, environmental activists and some scientists voted to adopt a moratorium on supporting research into gene drives. The moratorium call was rejected at the 2016 United Nations Convention on Biodiversity (CBD). Counter NGO groups, including Target Malaria, Island Conservation and Genetic Biocontrol of Invasive Rodents Program, have adopted the opposite position, stating that “gene drive is vital to the future of restoration and critical in preventing extinctions”.

Additional Resources

Click on a country (eg. Brazil, US) or region (eg. European Union) below to find which gene drive products and processes are approved or in development and their regulatory status.

European Union

European Union

Brazil

Brazil

New Zealand

New Zealand

United States

United States

Australia

Australia

Canada

Canada

China

China

United Kingdom

United Kingdom

Israel

Israel

Argentina

Argentina

Japan

Japan

Mexico

Mexico

Russia

Russia

Chile

Chile

Uruguay

Uruguay

Paraguay

Paraguay

India

India

Africa

Africa

Ukraine

Ukraine

Southeast Asia

Southeast Asia

Central America

Central America

Colombia

Colombia

Norway

Norway

Ecuador

Ecuador

Gene Drive 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: Gene drives regulated through existing biotechnology laws.
*Determined: No Unique Regulations: Gene and stem cell therapies regulated as phamaceuticals with no additional restrictions.

†Proposed: No Unique Regulations: Decrees under consideration for gene and stem cell therapies that would not require unique regulations beyond current restrictions on pharmaceuticals.

Gene Drives:
Genetic engineering technology used to transmit a characteristic throughout a wild population. For example, it can be used to develop mosquitoes that only have female offspring. If released into the wild, these mosquitoes would breed with wild malaria-carrying mosquitoes and over time would eliminate the population. Scientists are interested in using this technology to help eradicate disease-carrying insects and control invasive species, but questions about how gene drives will be directed and controlled are still being fleshed out.

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 / RegionGene DrivesGene Drive Rating
Japan11
Brazil88
Canada88
Russia11
Argentina11
Israel11
Australia44
China11
US44
Chile11
New Zealand44
Ukraine11
Central America11
Paraguay11
Uruguay11
India11
UK22
Mexico11
EU22
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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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