The FDA is considering approval of a genetically modified salmon for general consumption.
On September 3, the FDA issued a report which found that eating engineered salmon was as safe as eating any other salmon. This reprents an important step forward for AquaBounty Technologies, a Waltham, Mass., company that has been working on genetically modified salmon since 1989.
Genetic engineering is a targeted and powerful method of introducing desirable traits into animals using recombinant DNA (rDNA) technology. DNA is the chemical inside the nucleus of a cell that carries the genetic instructions for making living organisms.
In January, 2009, the Food and Drug Administration issued a final guidance for industry on the regulation of genetically engineered (GE) animals. The guidance explains the process by which FDA is regulating GE animals and provides a set of recommendations to producers of GE animals to help them meet their obligations and responsibilities under the law. While the guidance is intended for industry, FDA believes it may also help the public gain a better understanding of this important and developing area.
What is the FDA Doing?
Final Guidance Released 1/15/2009
- FDA Issues Final Guidance on Regulating Genetically Engineered Animals
- CVM GFI #187 Regulation of Genetically Engineered Animals Containing Heritable Recombinant DNA Constructs (PDF - 128KB)
- Fact Sheet
- General Q&A
- FDA's Response to Public Comments
- Genetically Engineered Animals Diagram
- January 15, 2009 Transcript for FDA’s Media Briefing on FDA's Release of a Final Guidance for Industry on the Regulation of Genetically-Engineered Animals (PDF - 65KB)
- Notice: Guidance for Industry on Regulation of Genetically Engineered Animals Containing Heritable recombinant DNA Constructs
- CVM Uses Seven-Step Process to Evaluate Safety, Effectiveness of GE Animals
- FDA Approves First Human Biologic Produced by GE Animals
- FDA Approves First GE Animal, Human Health Product
- FDA Releases Final Guidance on Genetically Engineered Animals
- Developments in New Animal Technologies Show Rapid Advancement: CVM Keeping Pace
- FDA Statement Regarding Glofish
- Reminder to Scientists Involved in Research with Genetically Engineered Animals
- CVM Participates in PEW Initiative Meeting on Transgenic Animals
- FDA RECEIVES NAS/NRC REPORT ON ANIMAL BIOTECHNOLOGY
- CVM Scientists Attend Conference on Transgenic Animals
- QUESTIONS AND ANSWERS ABOUT TRANSGENIC FISH
- How Transgenics are Produced
- WILL TRANSGENIC FISH BE THE FIRST AG-BIOTECH FOOD-PRODUCING ANIMALS?