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U.S. Department of Health and Human Services

About FDA

Fish SCALE (Seafood Compliance and Labeling Enforcement)

Description: Seafood is a highly valued, globally traded commodity, involving thousands of potentially marketable species. With over 90% of the seafood in the U.S. marketplace being imported, there is both opportunity and motivation to inaccurately label these products for economic gains. From FDA’s perspective, accurate labeling is a critical first step in both assessing potential risks associated with certain seafood products (i.e. processing related hazards, natural toxins, allergens, etc.) and in assuring consumers that they are getting what they pay for. The Fish SCALE project, performed in collaboration with the Office of Food Safety (OFS), Office of Compliance (OC), and Office of Regulatory Affairs (ORA) involves the development and implementation of regulatory genetic methods that will allow the FDA, other regulatory agencies, and the seafood industry to confirm seafood labeling and identify at which step in the supply chain that these violations are occurring.

Briefing Status: ON TRACK

Prior Briefing Status: ON TRACK

Milestone DescriptionMilestone DateMilestone StatusMilestone Completion Date

A. Develop a regulatory genetic method to identify processed fish filets

4/15/2013

Completed 4/15/2013

B. Build a reference library of DNA sequences for commercial fish

4/15/2013

Completed 4/15/2013

C. With ORA, equip, train, and proficiency test multiple FDA regional field laboratories in fish identification methodology

7/15/2013

Completed 7/15/2013

D. Develop an on-line repository for Standard Operating Procedures (SOPs) and for DNA species reference data for full transparency with other regulatory agencies and industry

7/15/2013

Completed 7/15/2013

E. Make this on-line repository cross-talk with FDA public resources for proper seafood labeling such as the Seafood List: FDA’s Guide to Acceptable Market Names for Seafood Sold in Interstate Commerce

7/15/2013

Completed 7/15/2013

F. In conjunction with OFS, OC, and ORA, perform targeted field sampling assignments for high risk species to assess where in the supply chain mislabeling is occurring

7/15/2013

Completed 7/15/2013

G. Develop multi-laboratory validation protocol for fish and crustaceans identification method for submission to FDA Chemical Methods Validation Committee

10/15/2013

(4/15/2014)

Not Yet Started

H. Perform an inter-agency, multi-laboratory validation of fish identification method

7/15/2014

Not Yet Started

I. Develop a regulatory genetic method to identify crab and lobster products

1/15/2014

Completed 1/15/2014

J. Build a reference library for commercial crab and lobster species and add to on-line seafood identification repository

4/15/2014

On Track

K. Develop SOPs, train regional FDA field laboratories and perform proficiency testing in crab and lobster identification methods

7/15/2014

Not Yet Started

L. Develop a genetic method to identify shrimp products

10/15/2014

On Track

M. Build a reference library for commercial shrimp species and add to on-line seafood identification repository

1/15/2015

On Track

N. Develop SOPs, train regional FDA field laboratories and perform proficiency testing in shrimp identification method

4/15/2015

Not Yet Started

Footnotes

  • The dates in italics under the milestone due dates are modified milestone due dates which had to be updated due to real-time delays. The milestone status reflects the revised dates.

Key Projects Legend

Milestone StatusDefinition
Not Yet StartedWork for specific milestone has not yet been started.
CompletedMilestone and/or overall project is completed.
On TrackMilestone - On track for completion by milestone deadline. Quarter status - Project is on track for completion based on overall milestone status.
On HoldMilestone - On hold, but deadline for completion has not passed. Quarter status - Project is on hold, based on overall milestone status.
DelayedMilestone - Delayed as it has not been completed and deadline has passed. Quarter status - Project is delayed based on overall milestone status.

Glossary

Note: The data provided on this website is produced on an ongoing basis for performance management purposes and is subject to change due to updates of preliminary estimates, corrections, or other reasons. In addition, FDA may change the type or amount of data provided on this website at any time. Information marked as "Completed" may include measures and/or key projects for which activities are ongoing but no longer tracked as part of FDA-TRACK.