Skip to main content
          Skip to FDA Search
          Skip to in this section menu
          Skip to footer links


U.S. flagAn official website of the United States government

					Here’s how you know
          			Dot gov**The .gov means it’s official.**Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.
							      SSL**The site is secure.** The **https://** ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. 
			U.S. Food and Drug Administration
				
        Search
            Menu
							
						Search FDA
									
									Submit search 
		Featured
							Contact FDA
	                FDA Guidance Documents
	                Recalls, Market Withdrawals and Safety Alerts
	                Press Announcements
	                Warning Letters
	                Advisory Committees
	                En Español

					Products
            Food
							Drugs
							Medical Devices
							Radiation-Emitting Products
							Vaccines, Blood, and Biologics
							Animal and Veterinary
							Cosmetics
							Tobacco ProductsTopics
            About FDA
							Combination Products
							Regulatory Information
							Safety
							Emergency Preparedness
							International Programs
							News and Events
							Training and Continuing Education
							Inspections and Compliance
							Science and ResearchInformation For
            Consumers
	            Patients
	            Industry
	            Health Professionals
	            Federal, State and Local Officials 
 In this section:

                Reference Databases and Monitoring Programs (Food)

Reference Databases and Monitoring Programs

                        


                        FDA Total Diet Study (TDS) Home
          Food
          Science & Research (Food)
          Reference Databases and Monitoring Programs (Food)
          DNA-based Seafood IdentificationReference Databases and Monitoring Programs (Food) DNA-based Seafood Identification
  
  	
    Share
    Post
    Linkedin

    Email
    PrintSeafood is one of the most highly traded commodities in the world. In the interest of public health, it is vital that both domestically processed and imported seafood is safe, wholesome, and properly labeled. To aid in the proper labeling of seafood, the Food and Drug Administration (FDA) maintains a list of acceptable market names for seafood sold in U.S. interstate commerce: The Seafood List - FDA’s Guide to Determine Acceptable Seafood Names.

Several years ago, the Food and Drug Administration (FDA) produced a web-based resource known as the Regulatory Fish Encyclopedia (RFE) to aid in the identification of commercially important species of fish (1). Organized in a series of species "pages," the RFE contains high resolution images of whole fish and their marketed product forms (e.g. fillets, steaks), as well as other taxonomic, geographic, and relevant tools for species identification. An example of an identification method listed in the RFE is protein identification by isoelectric focusing (2). Isoelectric focusing is a currently accepted tool employed in the identification of fish fillets for regulatory use, but such analysis requires subjective interpretations of gel results and the inclusion of perishable frozen tissue standards in each run. Further, the technique is not effective in the case of processed or cooked samples. The RFE was designed so that it could be expanded to include additional data and to accommodate the use of newer analytical tools as they became available. In 2007, using methods developed as part of the Barcode of Life initiative, DNA barcode sequences were generated for fish contained in the RFE and the utility of DNA barcoding for regulatory seafood identifications was demonstrated. (3)

The Barcode of Life initiative represents an ambitious effort to develop an identification system for eukaryotic life based upon the analysis of sequence diversity in short, standardized gene regions. Work is furthest advanced for members of the animal kingdom. In this case, a region of the cytochrome c oxidase subunit 1 gene (COI) has been targeted and pilot studies have shown its effectiveness in species identification. The Fish Barcode of Life campaign (FISH-BOL) is a collaborative international research effort which seeks to establish a reference library of DNA barcodes for all fish species derived from voucher specimens with authoritative taxonomic identifications (4). Fishes comprise nearly half of all vertebrate species; the group includes approximately 15,700 marine and 13,700 freshwater species (FishBase).

FDA's Center for Food Safety and Applied Nutrition (CFSAN) and Center for Veterinary Medicine (CVM), in collaboration with the University of Guelph's Biodiversity Institute of Ontario, Canadian Center for DNA Barcoding, and the Laboratories of Analytical Biology at the Smithsonian National Museum of Natural History, Suitland, MD, USA, first provided details on protocols, reagents, and equipment required to carry out a validation study for barcode generation for fish identification in the form of FDA Laboratory Information Bulletin No. 4420) (5). In 2008, this protocol was evaluated by three laboratories in an inter-laboratory trial and the results of this trial were used to further refine the method. This modified version of the method was then subjected to a formal single laboratory validation (SLV) at CFSAN and published in the Journal of AOAC (6). A step by step protocol based on this published SLV study, with minor modifications, is provided below. For FDA purposes, this SOP is intended to replace LIB No. 4420.

Literature Cited

Tenge BJ, Dang NL, Fry FS, Savary WE, Rogers PL, Barnett JD, Hill WE, Wiskerchen JE, Wekell MM. (1997). **Integration of Computer and Laboratory Techniques for Species Identification Including Development of a Regulatory Fish Encyclopedia. in Fish Inspection**, Quality Control, and HACCP - A Global Focus, p. 214-226. Martin, Collette, and Slavin, (eds.), Technomic Publishing, Lancaster, PA.
	AOAC. (1980). **Official Method 980.16 Identification of Fish Species: Thin-Layer Polyacrylamide Gel Isoelectric Focusing Method**. *J. AOAC* **63**:69 (1980); corr. 684.
	Yancy HF, Zemlak TS, Mason JA, Washington JD, Tenge BJ, Nguyen NT, Barnett JD, Savary WE, Hill WE, Moore MM, Fry FS, Randolph SC, Rogers PL and Hebert PDN. (2008a). The**Potential Use of DNA Barcodes in Regulatory Science: Applications of the Regulatory Fish Encyclopedia**. *J. Food Prot.* **71**(1):210-7.
	Ward RD, Hanner R, Hebert PDN. (2009). **The Campaign to DNA Barcode all Fishes, FISH-BOL.** *J. Fish Biol.* **74**:329-356.
	Yancy HF, Fry FS, Randolph SC, Deeds JR, Ivanova NV, Grainger CM, Hanner R, Weigt LA, Driskell A, Hunt J, Ormos A, Hebert PDN. (2008b) LIB No. 4420: **A Protocol for Validation of DNA-Barcoding for the Species Identification of Fish for FDA Regulatory Compliance.** FDA Laboratory Information Bulletin Vol. 24.
	Handy, SM, Deeds, JR, Ivanova, NV, Hebert, PDN, Hanner, R, Ormos, A, Weigt, LA, Moore, M, Yancy, HF. (2011).**A single laboratory validated method for the generation of DNA barcodes for the identification of fish for regulatory compliance.** *J. AOAC.***94**(1):201-210. A Protocol based on this publication is available (accessed 4/23/2014).Resources

Reference Standard Sequence Library for Seafood Identification
	Single Laboratory Validated Method for DNA-Barcoding for the Species Identification of Fish for FDA Regulatory Compliance
	Fish and Fishery Products Hazards and Controls Guidance - Fourth Edition
	Guidance for Industry: The Seafood List

                                                                                  Content current as of:
      01/30/2024
              
              
Regulated Product(s)
		 Food & Beverages
			  			     			  						              
			
			
			
			
			
						  Seafood/Seafood ProductReference Databases and Monitoring Programs

          
                        


                        FDA Total Diet Study (TDS)
 
 Footer Links
    FDA Archive
          About FDA
          Accessibility
      Visitor Information
          Website Policies / Privacy
          No FEAR Act
          Vulnerability Disclosure Policy
      FOIA
          HHS.gov
          USA.gov
    Contact FDA
      Follow FDA on Facebook
      Follow FDA on X
      Follow FDA on Instagram
      Follow FDA on LinkedIn
      View FDA videos on YouTube
      Subscribe to FDA RSS feeds
    FDA Homepage
    Contact Number
      1-888-INFO-FDA (1-888-463-6332) Back toTop