- Docket Number:
- Issued by:
Guidance Issuing OfficeCenter for Veterinary MedicineCenter for Food Safety and Applied Nutrition
Issued November 2015
Revised March 2019
This document provides guidance intended to assist food manufacturers that wish to voluntarily label their food products or ingredients (for humans or animals) derived from Atlantic salmon as either containing or not containing products from genetically engineered (GE) Atlantic salmon. This document also provides guidance on voluntary statements that may be appropriate for species of salmon that have no GE counterparts. FDA’s main concern within the context of this guidance is that such voluntary labeling be truthful and not misleading.
FDA’s guidance documents, including this guidance, 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.
In this guidance, we use the terms “bioengineering,” “bioengineered,” and “genetic engineering” to describe the use of modern biotechnology. Modern biotechnology means the application of in vitro nucleic acid techniques, including recombinant deoxyribonucleic acid (DNA) and direct injection of nucleic acid into cells or organelles, or fusion of cells beyond the taxonomic family, that overcome natural physiological reproductive or recombinant barriers and that are not techniques used in traditional breeding and selection (Ref. 1). The term “modern biotechnology” may alternatively be described as “recombinant DNA (rDNA) technology,” “genetic engineering,” or “bioengineering.” These terms are often used interchangeably by industry, federal agencies, international bodies, and other interested stakeholders and are used in this guidance to refer to foods developed using modern biotechnology. For the purpose of this guidance, FDA will primarily use the term “genetic engineering” or “GE” to describe the use of modern biotechnology in Atlantic salmon. FDA considers the term “genetic modification” to be a much broader term that encompasses other means of altering the genome of an organism including selective breeding, and lab-based in vitro methods. Genetic engineering is thus a subset of genetic modification.
With regard to animals, FDA regulates GE animals under the new animal drug provisions of the Federal Food, Drug, and Cosmetic Act (the FD&C Act). We described our process and authority for regulating GE animals in a 2009 Guidance for Industry, 187, “Regulation of Genetically Engineered Animals Containing Heritable Recombinant DNA Constructs” (GFI 187). (Ref. 2).
As explained in GFI 187, in general, a new animal drug must be the subject of an approved new animal drug application (NADA) unless it is the subject of an investigational exemption or is used in conformance with regulations promulgated under sections 512(a)(4) or (a)(5) of the FD&C Act (21 U.S.C. 360b(a)(4) or (a)(5)).
On November 19, 2015, FDA approved a new animal drug application (NADA) for an rDNA construct in a line of farm-raised Atlantic salmon known as AquAdvantage Salmon. This is FDA’s first approval of a NADA related to a GE animal intended for use as food. AquAdvantage Salmon is genetically engineered to reach market size in a shorter period of time than do non-GE farm-raised Atlantic salmon. Because section 201(f)(1) of the FD&C Act (21 U.S.C. 321(f)) defines “food” as “articles used for food or drink for man or other animals,” the food from GE and other Atlantic salmon addressed in this guidance include Atlantic salmon (and the products derived from Atlantic salmon) used as food for humans as well as for animals.
For simplicity we use the term “genetically engineered Atlantic salmon” in this guidance to refer to food products that are derived from genetically engineered Atlantic salmon, as well as to the GE Atlantic salmon itself.
- Voluntary Labeling Indicating Whether Foods Have or Have Not Been Derived from Genetically Engineered Plants
- More on AquAdvantage Salmon
- Background on the Public Hearing on the Labeling of Food Made from the AquAdvantage Salmon
- More Labeling Guidance
- More Biotechnology Guidance
You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))
If unable to submit comments online, please mail written comments to:
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-2015-D-4272.