Q: What is genome editing?
A: “Genome editing” is a term used to describe a relatively new set of technologies that enable one to make precise changes in the DNA of a plant, animal or other living organism. For example, such technologies can be used to introduce, remove, or substitute one or more specific nucleotides at a specific site in the organism’s genome. Genome editing is being performed using, for example, clustered regulatory interspersed short palindromic repeat associated nucleases (CRISPR), zinc-finger nucleases (ZFNs), transcription activator-like effector nucleases (TALENs), and oligonucleotide-directed mutagenesis (ODM).
Q: What is FDA doing in this area?
On January 18, 2017, FDA announced a Request for Comments (RFC) seeking public input to help inform its regulatory approach to human and animal foods derived from plants produced using genome editing. The RFC asks for data and information in response to questions about the safety of foods from genome edited plants, such as whether categories of genome edited plants present food safety risks different from other plants produced through traditional plant breeding.
Additionally, the agency asked for information on how best to engage small businesses, including those that may be considering using genome editing to produce new plant varieties for use in human or animal food.
On April 13, 2017, the FDA extended the comment period for the Request for Comment to June 19, 2017. Comments received will help inform FDA's thinking on human and animal foods derived from new plant varieties produced using genome editing.
The FDA intends to release draft guidance in 2019.
Q: Why is the FDA requesting information from the public regarding crops used for human and animal food that have been produced through the use of genome editing?
A: In September 2016, OSTP issued a National Strategy for Modernizing the Regulatory System for Biotechnology Products (the Strategy), which sets out a vision for ensuring that the federal regulatory system is prepared to assess future products of biotechnology. In addition, in January 2017, OSTP issued a 2017 Update to the Coordinated Framework (CF) for the Regulation of Biotechnology (the CF Update), which clarifies the current roles and responsibilities of, and coordination among, FDA, the Environmental Protection Agency (EPA), and the U.S. Department of Agriculture’s Animal and Plant Health Inspection Service (USDA/APHIS).
In the Strategy, the FDA noted its intent to clarify its policy for the regulation of products derived from genome editing techniques. As an initial step, the FDA invites comments in response to specific questions relevant to the regulation of foods from plants produced using genome editing. Responses received will help inform the FDA’s thinking about foods derived from plants produced using genome editing.
Q: What responsibilities do developers have if they want to bring to market a product derived from a plant developed using genome editing technologies?
A: Any company looking to market foods made with genome editing techniques is responsible for complying with all applicable laws and regulations. For more than 20 years, developers have routinely consulted FDA about the safety and regulatory status of foods from new genetically engineered plant varieties prior to marketing. FDA intends to continue offering consultations for developers of new plant varieties, including those produced using genome editing, in order to help developers ensure that applicable safety and legal questions are resolved prior to marketing of food products derived from such new plant varieties.
Q: Has the FDA completed any voluntary consultations for genome edited plant varieties intended for animal or human food?
A: The FDA completed our first voluntary food safety consultation on food derived from a plant produced using genome editing in February 2019. The FDA maintains a publicly available inventory of completed consultations on food from new plant varieties.
Q: Is FDA working with other federal agencies on the regulation of products developed through genome editing?
A: Regulatory oversight of genome editing and its applications is being considered within the umbrella of ongoing work under the White House Office of Science and Technology Policy (OTSP)-initiated effort to modernize the federal regulatory system for biotechnology products. The U.S. Government initiated this effort in 2015 to ensure public confidence in the regulatory system for biotechnology products and improve the transparency, predictability, coordination, and, ultimately, the efficiency of that system.
In January 2017, OSTP issued a 2017 Update to the Coordinated Framework (CF) for the Regulation of Biotechnology (the CF Update), which clarifies the current roles and responsibilities of, and coordination among, FDA, EPA, and USDA/APHIS. In addition, in September 2016, OSTP issued a National Strategy for Modernizing the Regulatory System for Biotechnology Products (the Strategy), which sets out a vision for ensuring that the federal regulatory system is prepared to assess future products of biotechnology.
Consistent with the Update to the CF, FDA continues to work closely with EPA and USDA/APHIS on various issues related to biotechnology, including on genome editing. We note that APHIS has proposed to revise its regulation regarding genetically engineered organisms that may pose plant pest or noxious weed risks. We intend to work cooperatively with other relevant agencies that may also be considering their policies or approaches related to genome editing applications within their jurisdictions.
For more information:
- Modernizing the Regulatory System for Biotechnology Products
- Biotechnology Products at CVM: Animals and Animal Food
- Q&A on FDA Regulation of Intentionally Altered Genomic DNA in Animals