Import Alert 99-40

(Note: This import alert represents the Agency's current guidance to FDA field personnel regarding the manufacturer(s) and/or products(s) at issue. It does not create or confer any rights for or on any person, and does not operate to bind FDA or the public).

Import Alert # 99-40
Published Date: 07/20/2017
Type: DWPE with Surveillance

Import Alert Name:

GENETICALLY ENGINEERED (GE) SALMON

Reason for Alert:

NOTE: The revision to this Import Alert dated 07/20/2017 updates the Reason for Alert section as the Fiscal Year (FY) 2017 Omnibus Appropriations was signed into law. Previous revisions to this Import Alert dated 9/30/2016 provided clarification that the directive under Public Law No. 114-113 remained in effect under Continuing Resolutions. Changes are noted and bracketed with three asterisks (***).

*** The Fiscal Year (FY) 2017 Omnibus Appropriations Act covering the funding of the federal government during fiscal year 2017 (FY17) was signed into law by the President on May 5, 2017 becoming Public Law 115-31. In part, this law directs that during FY17 the FDA shall not allow the introduction or delivery for introduction into interstate commerce of any food that contains genetically engineered salmon, until FDA publishes final labeling guidelines for informing consumers of such content. This language was also found in the FY16 Omnibus Appropriations Act. The directive under Public Law No. 115-31 remains in effect under Continuing Resolutions (barring any language to the contrary) passed prior to the passage of the Fiscal Year 2018 Omnibus Appropriations Act. When the FDA receives and reviews the 2018 Omnibus Appropriations Act or FDA finalizes the guidelines as directed, the Import Alert will be modified accordingly or deactivated.***

Guidance:

Any shipment of suspected or known GE salmon or product composed in whole or in part of GE salmon should be promptly forwarded to the District Compliance Branch. Division staff should immediately contact the Division of Import Operations Management (DIOM) and CFSAN OC/DE regarding human food shipments and DIOM and CVM/OSC/DC regarding animal food shipments.

Under no conditions should the entry be released without concurrence from both DIOM (FDAImportsInquiry@fda.hhs.gov) and CFSAN OC/DE (CFSANDivisionofEnforcement@fda.hhs.gov) for human food or DIO and CVM/OSC/DC for animal food. (CVMImportRequests@fda.hhs.gov).

Contact CFSAN, Office of Compliance, Division of Enforcement, at CFSANDivisionofEnforcement@fda.hhs.govfor questions on human food policy.

Contact CVM, Office of Surveillance and Compliance, Division of Compliance, at CVMImportRequests@fda.hhs.gov for questions on animal food policy.

Questions or issues involving import operations should be addressed to ORA/DIOM, at (301) 796-0356 or FDAImportsInquiry@fda.hhs.gov

Product Description:

HUMAN FOOD CONTAINING GENETICALLY ENGINEERED SALMON;
ANIMAL FOOD CONTAINING GENETICALLY ENGINEERED SALMON

Charge:

N/A

Countries

MULTIPLE COUNTRIES (PODS ONLY)

  • (16 X - - 03) Salmon, all, Aquaculture Harvested Fishery/Seafood Products
  • (16 A - - 32) Salmon (Humpback, Silver, King, Sockeye, Etc.)
  • (16 B - - 32) Salmon (Humpback, Silver, King, Sockeye, Etc.), Breaded
  • (16 C - - 32) Salmon (Humpback, Silver, King, Sockeye, Etc.), Cakes, Balls, Etc.
  • (16 I - - 32) Salmon (Humpback, Silver, King Sockeye, etc.), Hot Smoked, Fish
  • (16 S - - 32) Salmon (Humpback, Silver, King, Sockeye, etc.), Cold Smoked, Fish
  • (71 D - - 01) Cond Fish Soluble
  • (71 D - - 03) Fish Meal
  • (71 D - - 99) Marine Byproducts, N.E.C.
  • (72 B - - 03) Fish-Seafood Prod Pet Dog Food
  • (72 D - - 01) Meat Pet Fish Food
  • (72 D - - 02) Grain Pet Fish Food
  • (72 D - - 03) Veg Pet Fish Food
  • (72 D - - 04) Comb Prod Pet Fish Food