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United States: Animals

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Highly Regulated

Gene edited animals regulated as drugs and subject to extensive safety testing.

Although genetically engineered crops are regulated by the USDA, which is liberalizing its oversight of gene editing, animal biotechnology is overseen by the Food and Drug Administration (FDA) based on an unusual reading of the federal 1938 Food, Drug and Cosmetic Act, and the FDA regulates gene editing very strictly.

In a 2017 draft guidance, the FDA proposed that all intentional genome alterations in animals will be regulated as a veterinary drug. This includes many of the same DNA insertions, substitutions, or deletions that could be obtained using conventional breeding. No longer is it the presence of a foreign gene that triggers mandatory premarket FDA regulatory oversight of genetically engineered animals, but rather the presence of any “intentionally altered DNA” in an animal’s genome that triggers regulation. No other country has taken this approach.

In 2018, the FDA announced a plan to clarify gene editing policies and create a clearer path to market for gene edited animals. The plan is expected to be risk-based, which means animals that are low risk would require minimal regulation. In 2019, the FDA started to identify animals with altered DNA that would be low-risk, and exempt from a safety review. However, in 2020, the FDA released a statement using a new analysis of gene editing in cattle to defend its 2017 decision to require that every animal created by gene editing should be subject to mandatory premarket review and substantial safety testing. Scientists responded in an editorial, saying the agency’s position is at odds with the evidence, and that it appears designed to avoid legal battles with anti-GMO groups.

As a result of these uniquely strict regulations, no food from a genetically engineered animal has ever reached the US market. Some American scientists have relocated their gene editing research programs outside the country, particularly to Brazil, and others have formally written that the new animal drug regulatory approach is not “fit for purpose”. The National Pork Producers Council and other agricultural groups have petitioned the USDA to take over regulating gene edited animals because they regulate gene edited crops, but the FDA rejected this proposal.

Products/Research

Regulatory Timeline

2020: FDA releases statement arguing that a new analysis indicates gene editing in cattle can have unintended consequences and supports the FDA decision to highly regulate to animal biotechnology. Scientists respond in an editorial claiming the agency’s position is at odds with the evidence, and that it appears designed to avoid legal battles with anti-GMO groups.

2019: Over 300 scientists sign a petition calling for the Harmonization of US gene-edited food regulations, asking that gene editing regulations for animals be the same as for crops and food.

2019: The National Pork Producers Council and other agricultural groups mount a campaign to transfer regulatory responsibilities to the USDA, which regulates gene edited crops, but the FDA rejected the proposal.

2019: An executive order is signed, known as Modernizing the Regulatory Framework for Agricultural Biotechnology Products, directing federal agencies (USDA, FDA and EPA) to exempt low-risk products from regulation and to create a unified platform that clearly outlines all regulatory requirements for approval of products developed with biotechnology.

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: GMO Labeling Act passed, which requires labeling of genetically engineered food products. It is not yet clear whether gene edited animals will require such a label.

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 regulating DNA used to genetically engineer animals as a drug.

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.

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

The Center for Food Safety and other NGOs have said they will fight against weakening animal regulations if the FDA decides that any gene edited animals should not be strictly regulated as drugs.

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.