A Public Resource Compiled by the

United States: Crops / Food

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NO UNIQUE REGULATIONS

Most gene-edited crops are regulated as conventional plants, so they don’t face the heavier restrictions of GMOs.

The US lightly regulates gene edited crops and food, although the situation is complicated by the overlapping roles of three different agencies (USDA, FDA and EPA), each with separate regulations as outlined under the 1986 US Coordinated Framework for Biotechnology. The US regulates the characteristics of the product itself and not the process to develop it. Gene edited crops lacking foreign genes (which trigger regulation as GMOs) and that do not pose a risk to other plants, and gene edited food showing no food safety attributes different from those of traditionally bred crops, are not subject to regulatory evaluation.

For years, it was unclear how gene editing would be regulated as gene editing techniques engineer new plants without foreign DNA. In 2018, the USDA’s Animal and Plant Health Inspection Service (USDA-APHIS) announced it would not regulate gene edited plants “similar to those found naturally” but there remained much confusion. In 2019, USDA proposed a reduction in regulatory requirements for most gene edited plants and a more efficient regulatory pathway. This new regulation would reaffirm a focus on regulating characteristics of gene edited plants, instead of the process used to create them, as is the case in the EU. The FDA (which oversees food safety) and EPA (which regulates pesticides) have not announced if they will regulate gene-edited crops and food. In 2019, the President signed an executive order directing federal agencies to streamline the regulatory process for genetically engineered plants by exempting low-risk products from regulation and creating a unified platform that clearly outlines all regulatory requirements (from all three agencies) for approval of products developed with biotechnology.

To date only one gene edited product has been commercialized, a soybean oil that contains “up to 20% less saturated fatty acids” compared to commodity soybean oil.

Products/Research

Regulatory Timeline

2019: Modernizing the Regulatory Framework for Agricultural Biotechnology Products, an executive order, directs 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.

2019:  USDA-APHIS proposes new biotechnology framework, 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: FDA announces 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.

2018: US Secretary of Agriculture, Sonny Perdue, declares that the USDA does not regulate or have any plans to regulate plants that could otherwise have been developed through traditional breeding techniques.

2017: After objections from scientists,  USDA withdraws proposed rule to revise the agency’s regulations of genetically engineered crops, which would have increased regulations on gene edited crops, and instead agrees that gene edited plants should be treated similarly to those developed through conventional breeding techniques.

2017: Office of Science and Technology (ODTP)  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: The GMO Labeling Act requires labeling of genetically engineered food products. It gives the option for companies to use a QR code that consumers can scan to see if the product is made from genetically engineered food products. It is not clear whether gene edited ingredients will trigger such a label.

2016: OSTP issues 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.

2000: The Plant Protection Act authorizes APHIS to regulate any plant, plant product or organism that could injure, damage, or cause disease in any plant or plant product.

1986:  Coordinated Framework for the Regulation of Biotechnology outlines the basic federal policy of the agencies (USDA, FDA and EPA) involved with reviewing biotechnology research and products.

1910:  Federal Insecticide, Fungicide and Rodenticide Act authorizes the EPA to regulate pesticide distribution, sale, and use, including plants genetically modified to produce pesticides.

NGO Reaction

Environmental advocacy groups including Greenpeace, Center for Food Safety, Environmental Working Group and Friends of the Earth, have taken the stance that gene editing is just the newest version of transgenic modification (GMO 2.0), arguing that gene editing has not been tested enough for safety and could lead to unintended side effects.

Additional Resources

Click on countries (eg. Brazil, US) or regions (eg. European Union) to find what agricultural products or therapies are approved or in development and their regulatory status.

Hotspots Background

European Union

EUROPEAN UNION

 

Agricultural Gene Editing
- Crops / Food
- Animals

 

Human Gene Editing
- Therapeutic / Stem Cell
- Germline / Embryonic

 

Gene Drives

 

Brazil

BRAZIL

 

Agricultural Gene Editing
- Crops / Food
- Animals

 

Human Gene Editing
- Therapeutic / Stem Cell
- Germline / Embryonic

 

Gene Drives

 

New Zealand

NEW ZEALAND

 

Agricultural Gene Editing
- Crops / Food
- Animals

 

Human Gene Editing
- Therapeutic / Stem Cell
- Germline / Embryonic

 

Gene Drives

 

United States

UNITED STATES

 

Agricultural Gene Editing
- Crops / Food
- Animals

 

Human Gene Editing
- Therapeutic / Stem Cell
- Germline / Embryonic

 
 

Gene Drives

 

Australia

AUSTRALIA

 

Agricultural Gene Editing
- Crops / Food
- Animals

 

Human Gene Editing
- Therapeutic / Stem Cell
- Germline / Embryonic

 

Gene Drives

 

Canada

CANADA

 

Agricultural Gene Editing
- Crops / Food
- Animals

 

Human Gene Editing
- Therapeutic / Stem Cell
- Germline / Embryonic

 
 

Gene Drives

 

China

CHINA

 

Agricultural Gene Editing
- Crops / Food
- Animals

 

Human Gene Editing
- Therapeutic / Stem Cell
- Germline / Embryonic

 
 

Gene Drives

 

United Kingdom

UNITED KINGDOM

 

Agricultural Gene Editing
- Crops / Food
- Animals

 

Human Gene Editing
- Therapeutic / Stem Cell
- Germline / Embryonic

 
 

Gene Drives

 

Israel

ISRAEL

 

Agricultural Gene Editing
- Crops / Food
- Animals

 

Human Gene Editing
- Therapeutic / Stem Cell
- Germline / Embryonic

 
 

Gene Drives

 

Argentina

ARGENTINA

 

Agricultural Gene Editing
- Crops / Food
- Animals

 

Human Gene Editing
- Therapeutic / Stem Cell
- Germline / Embryonic

 
 

Gene Drives

 

Japan

JAPAN

 

Agricultural Gene Editing
- Crops / Food
- Animals

 

Human Gene Editing
- Therapeutic / Stem Cell
- Germline / Embryonic

 
 

Gene Drives

 

Mexico

MEXICO

 

Agricultural Gene Editing
- Crops / Food
- Animals

 

Human Gene Editing
- Therapeutic / Stem Cell
- Germline / Embryonic

 
 

Gene Drives

ARGENTINA

 

Agricultural Gene Editing
Crops / Food
Animals

 

Human Gene Editing
Therapeutic / Stem Cell
Germline / Embryonic

 
 

Gene Drives

 

AUSTRALIA

 

Agricultural Gene Editing
Crops / Food
Animals

 

Human Gene Editing
Therapeutic / Stem Cell
Germline / Embryonic

 

Gene Drives

 

BRAZIL

 

Agricultural Gene Editing
Crops / Food
Animals

 

Human Gene Editing
Therapeutic / Stem Cell
Germline / Embryonic

 

Gene Drives

 

CANADA

 

Agricultural Gene Editing
Crops / Food
Animals

 

Human Gene Editing
Therapeutic / Stem Cell
Germline / Embryonic

 
 

Gene Drives

 

CHINA

 

Agricultural Gene Editing
Crops / Food
Animals

 

Human Gene Editing
Therapeutic / Stem Cell
Germline / Embryonic

 
 

Gene Drives

 

EUROPEAN UNION

 

Agricultural Gene Editing
Crops / Food
Animals

 

Human Gene Editing
Therapeutic / Stem Cell
Germline / Embryonic

 

Gene Drives

 

ISRAEL

 

Agricultural Gene Editing
Crops / Food
Animals

 

Human Gene Editing
Therapeutic / Stem Cell
Germline / Embryonic

 
 

Gene Drives

 

JAPAN

 

Agricultural Gene Editing
Crops / Food
Animals

 

Human Gene Editing
Therapeutic / Stem Cell
Germline / Embryonic

 
 

Gene Drives

 

MEXICO


Agricultural Gene Editing
Crops / Food
Animals


Human Gene Editing
Therapeutic / Stem Cell
Germline / Embryonic



Gene Drives

NEW ZEALAND

 

Agricultural Gene Editing
Crops / Food
Animals

 

Human Gene Editing
Therapeutic / Stem Cell
Germline / Embryonic

 

Gene Drives

 

UNITED KINGDOM

 

Agricultural Gene Editing
Crops / Food
Animals

 

Human Gene Editing
Therapeutic / Stem Cell
Germline / Embryonic

 
 

Gene Drives

 

UNITED STATES

 

Agricultural Gene Editing
Crops / Food
Animals

 

Human Gene Editing
Therapeutic / Stem Cell
Germline / Embryonic

 
 

Gene Drives