The USDA’s Food Safety Inspection Service (“FSIS”) issued a final policy statement earlier this week that changes the agency’s practices regarding the application of the mark of inspection when FSIS test results for pathogens remain pending. The Agency’s practice had been to allow products tested for adulterants to bear the mark of inspection, and to enter commerce, even when the FSIS test results for pathogens have not been received, as stated in the FSIS notice published on April 11, 2011 (76 FR 19952).

Under the new policy, FSIS will not apply the mark of inspection until negative results are available and received for any testing for adulterants conducted by FSIS. The rationale for the change is that while FSIS requested that establishments maintain product under their control pending the test outcomes, certain establishments were introducing products into commerce despite pending tests, thereby increasing the risk of adulterated product in the marketplace.

The FSIS administers the Federal Meat Inspection Act (“FMIA”) and the Poultry Products Inspection Act (“PPIA”). These statutes prohibit anyone from selling, transporting, offering for sale or transportation, or receiving for transportation in commerce, any adulterated or misbranded meat or poultry products. The policy change applies to a subset of meat and poultry as follows:

  • Non-intact raw beef product or intact raw beef product intended for non-intact use that is tested for E. coli 0157:H7
  • Ready-to-eat (“RTE”) products tested for listeria monocytogenes, E. coli 0157:H7, or salmonella, and RTE products that passed over food contact surfaces that have been tested for the presence of listeria monocytogenes and salmonella, pending receipt of negative test results
  • Livestock carcasses subject to FSIS testing for veterinary drugs such as antibiotics, sulfonamides, or avermectins or the feed additive carbadox

The new policy applies only to FSIS testing and does not apply to establishment testing. FSIS intends to monitor the degree to which establishments release product pending establishment test results and will request recall of any product that is released and later found to have tested positive for pathogens. The policy change also does not cover FSIS testing for the following products:

  • Raw meat or poultry products tested for salmonella or other pathogens that FSIS has not designated as adulterants in those products
  • Poultry carcasses

The new policy will be effective on February 8, 2013. Prior to implementation, FSIS will issue instructions reiterating to inspection program personnel that they are to provide establishments prior notification of FSIS sampling for adulterants. Further, to minimize the impact on small businesses and production of products with short shelf life (e.g., chicken salad), such establishments will be allowed to produce and hold small product batches for sampling purposes. FSIS intends to issue new guidance for small and very small businesses regarding production of small batches for sampling purposes.

The agency’s notice and final policy announcement also address concerns raised regarding imported product, control over product, lot definition, economic adulteration, the retail exemption, enforcement, and downstream testing. Companies that are subject to FSIS jurisdiction should evaluate the new policy and consult their distribution and hazard analysis plans to ensure that they are prepared to meet the updated requirements.