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New Guidance Documents and Interim Final Rules under the Food Safety Modernization Act

Since the U.S. FDA Food Safety Modernization Act (FSMA) was passed earlier this year, U.S. FDA has released a handful of new mandated publications relating to food safety and imported food within the past few weeks: an updated Fish & Fisheries Products Hazards & Controls Guidance, an interim final rule for the administrative detention of food, and an interim final rule for the prior notice of refused imported food shipments.

The Fish & Fisheries Products Hazards & Controls Guidance is also known as the Seafood HACCP Guidance Document.  It was last updated in June 2001 and was recently re-issued in its fourth and most current version on April 27, 2011.  This guidance document clarifies the regulations in 21 CFR Part 123, which support the safe and sanitary processing of seafood products.  The newest version contains many changes from the third edition, such as an increase in the number of steps in creating a HACCP Plan from thirteen to eighteen; a final version of the Glass Inclusion chapter; and multiple new appendices for specialty concerns such as Japanese and Hawaiian vernacular names for sushi, bacterial and viral pathogens most concerning to public health, and extra procedures for the importation of seafood products.  While the new document may create additional work for some seafood processors, manufacturers must know that meeting U.S. FDA seafood HACCP requirements exempts the seafood processor from two new requirements that were instituted for all food manufacturers.  Seafood processors meeting U.S. FDA seafood HACCP requirements do not need to participate in the Foreign Supplier Verification Program (FSVP) and have, by definition of meeting seafood HACCP requirements, already met new HACCP requirements placed on all food manufacturers.

The interim final rule for the administrative detention of food was issued late last week on May 4, 2011, and clarifies that U.S. FDA, starting on July 3, 2011, will be able to detain food that the agency believes to have been produced or processed in unsanitary conditions.  This is a huge endowment of power as U.S. FDA was previously only able to accomplish this by working with state governments or for products for which unsanitary processing conditions could be proven.

The interim final rule for the prior notice of refused imported food shipments was issued late last week on May 4, 2011, and details that anyone importing food into the United States must declare to U.S. FDA if that same product has ever been denied entry into another country.  This new information will be submitted when a country completes Prior Notice, which is a program that was established in 2002 under the Bioterrorism Act.  The interim final rule states that this change can help U.S. FDA be better informed about potential risks of imported food products.

All of these new provisions allow both U.S. FDA and food manufacturers to be better prepared to prevent hazards and unsafe food, which directly support FSMA’s goal of a safe food supply.

A more in-depth analysis of these three new publications will be forthcoming.  Stay tuned.





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