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GUIDANCE DOCUMENT

Guidance for Industry: Foods Derived from Plants Produced Using Genome Editing February 2024

Download the Final Guidance Document
Final
Docket Number:
FDA-2019-D-4658
Issued by:
Guidance Issuing Office
Center for Food Safety and Applied Nutrition

A purpose of this guidance is to clarify how FDA’s policy statement “Statement of Policy: Foods Derived from New Plant Varieties” (NPV policy) (57 FR 22984, May 29, 1992) applies to foods[1] derived from new plant varieties produced using genome editing.[2]  The NPV policy provides scientific and regulatory guidance on foods from new plant varieties.  The NPV policy lays out broad, risk-based principles for ensuring the safety of foods from new plant varieties.  These principles are sufficiently flexible to accommodate foods from new plant varieties developed using a wide range of techniques.  This guidance explains that the principles outlined in the NPV policy apply to foods from genome-edited plant varieties.  This guidance also reminds developers of new plant varieties (developers) of their obligations under section 403(w) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), which was enacted after the issuance of our NPV policy.  In addition, this guidance describes two processes through which developers may voluntarily inform FDA of the steps they have taken to ensure the safety of foods from their new genome-edited plant varieties: voluntary premarket consultations and voluntary premarket meetings.  The voluntary process we recommend for a new food is based on the objective characteristics of the new food, especially those related to food safety.[3]   

In general, FDA’s guidance documents do not establish legally enforceable responsibilities.  Instead, guidances describe FDA’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited.  The use of the word should in FDA guidances means that something is suggested or recommended, but not required.

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Related Information

[1] For the purpose of this guidance, unless otherwise specified, “food” means human food and animal food.

[2] Genome editing methods are methods that can be used to produce new plant varieties by creating genetic changes at specific sites in the plant genome.  Using deoxyribonucleic acid (DNA) sequence information from a plant, plant breeders can make targeted changes to a plant’s DNA sequence to alter expression of traits in the plant.  These methods include processes using targeted nucleases (clustered regulatory interspaced short palindromic repeat (CRISPR) associated nucleases, zinc-finger nucleases, meganucleases, and transcription activator-like effector nucleases (TALENs)) or targeted oligonucleotides (oligonucleotide-directed mutagenesis) intended to modify a plant’s DNA sequence by insertion, deletion, or substitution of nucleotides at a specific site in a plant’s genome.  The process of producing these targeted DNA sequence alterations is often referred to as “genome editing.”

[3] While this guidance does not apply to the safety or legal status of plant incorporated protectants (PIPs) themselves, which are regulated by the Environmental Protection Agency (EPA), this guidance does apply to PIP-containing foods.  Specifically, this guidance applies to food safety aspects of a PIP-containing food in the event that a food safety concern is not associated with the PIP.  For example, this guidance applies to food-safety-related changes in the food that are not due to the presence of the PIP.  Consequently, developers producing plants that contain a PIP should consider this guidance as they develop new genome-edited plants intended for food use.

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Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2019-D-4658 .

 
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